Compendia Transparency Document

New Off-Label Uses

Monograph Off-Label Use Proposed Date Participating Panel Member(s) Strength of Recommendation Level of Evidence Off-Label Use Vote Record Panel Member Conflict of Interest Statement
Goserelin Prevention of early menopause during chemotherapy for early stage hormone receptor negative breast cancer 2015.03 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP
Equivocal B For the Off-Label Use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Cisplatin Breast cancer (triple-negative) 2015.04 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP
Equivocal B For the Off-Label Use: 4 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Cisplatin Penile cancer 2015.04 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Nick Link, PharmD, BCOP

Mark Holdsworth, PharmD
Equivocal B For the Off-Label Use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Idarubicin AML (Pediatric), relapsed/refractory 2015.04 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Mark Holdsworth, PharmD

Heidi Trinkman, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Strong (for off-label use) A For the Off-Label Use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Idarubicin AML (Pediatric), newly diagnosed 2015.04 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Mark Holdsworth, PharmD

Heidi Trinkman, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Equivocal B For the Off-Label Use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Topotecan Primary CNS lymphoma, relapsed/refractory 2015.06 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal C For the Off-Label Use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Nivolumab Melanoma, unresectable or metastatic (without BRAF mutation), first-line, single-agent therapy 2015.07 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS
Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Palbociclib Breast cancer, advanced (second-line endocrine-based therapy) 2015.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Omer Koc, MD

Nick Link. PharmD, BCOP

Strong A For the Off-Label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Fulvestrant Breast cancer, advanced (second-line endocrine-based combination therapy) 2015.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Omer Koc, MD

Nick Link. PharmD, BCOP

Strong A For the Off-Label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Cabozantinib Renal cell cancer, clear cell (advanced) 2015.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A For the Off-Label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Nivolumab Renal cell cancer, clear cell (advanced) 2015.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A For the off-label use: 4 of 5 No conflict of interest

No conflict of interest

Conflict of interest

No conflict of interest

No conflict of interest

Goserelin Breast cancer, advanced (second-line endocrine-based combination therapy [with palbociclib and fulvestrant] in pre- or peri-menopausal women) 2015.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link. PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Ipilimumab Melanoma, unresectable or metastatic, first-line combination therapy 2015.11 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link. PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Trabectedin Ovarian cancer, refractory (platinum-sensitive) 2016.02 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Docetaxel Prostate cancer, metastatic, hormone-sensitive 2016.03 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Defibrotide Hepatic sinusoidal obstruction syndrome, prevention (pediatrics) 2016.04 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Polly Kintzel, PharmD, BCOP, BCPS

Heidi Trinkman, PharmD

Mark Holdsworth, PharmD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Vemurafenib Erdheim-Chester disease, refractory (with BRAF V600E mutation) 2016.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Vemurafenib Non-small cell lung cancer, refractory (with BRAF V600 mutation) 2016.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Nivolumab Head and neck cancer, squamous cell (recurrent or metastatic) 2016.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Axitinib Thyroid cancer (advanced, differentiated) 2016.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Mark Holdsworth, PharmD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Carfilzomib Waldenström macroglobulinemia 2016.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Regorafenib Hepatocellular cancer (intermediate or advanced) 2016.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Mark Holdsworth, PharmD

Omer Koc, MD

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Pembrolizumab Merkel cell carcinoma (advanced) 2016.08 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Dabrafenib Non-small cell lung cancer, metastatic, relapsed or refractory (with BRAF V660E mutation) 2016.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Trametinib Non-small cell lung cancer, metastatic, relapsed or refractory (with BRAF V660E mutation) 2016.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Nivolumab Small cell lung cancer (progressive) 2016.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 4 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Mitomycin Vulvar cancer, advanced 2016.11 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Carboplatin Anal cancer 2016.12 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal C For the off-label use: 4 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Carboplatin Gastric cancer 2016.12 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Carboplatin Thyroid Cancer 2016.12 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B, G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Carboplatin Wilms Tumor 2016.12 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Mark Holdsworth, PharmD

Heidi Trinkman, PharmD

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Fluorouracil Vulvar cancer, advanced 2016.12 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Bevacizumab Malignant pleural mesothelioma (unresectable) 2016.12 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Bevacizumab Hereditary hemorrhagic telangiectasia 2016.12
(updated 2020.04)
Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Nick Link, PharmD, BCOP

Heidi Trinkman, PharmD

Equivocal C, G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Temsirolimus Endometrial cancer (locally advanced, recurrent and/or metastatic) 2017.02 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Pembrolizumab Urothelial carcinoma (advanced) 2017.02 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Sargramostim Neuroblastoma, high-risk (pediatrics) 2017.03 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Heidi Trinkman, PharmD

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Isotretinoin Neuroblastoma, high-risk (pediatrics) 2017.04 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Polly KIntzel, PharmD, BCOP, BCPS

Heidi Trinkman, PharmD

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Ipilimumab Small cell lung cancer (progressive) 2017.04 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 4 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Tocilizumab Cytokine release syndrome (due to BiTE therapy), severe or life-threatening 2017.04 (modified 2017.09) Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Polly Kintzel, PharmD, BCOP, BCPS

Heidi Trinkman, PharmD

Omer Koc, MD

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Capecitabine Pancreatic cancer (adjuvant therapy) 2017.04 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Gemcitabine Pancreatic cancer (adjuvant therapy) 2017.04 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Capecitabine Anal carcinoma 2017.04 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Antithymocyte globulin (rabbit;Thymoglobulin) Chronic graft-versus-host disease (prevention) 2017.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A, G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Olaparib Breast cancer, metastatic, HER2-negative, BRCA-mutated 2017.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Abiraterone Prostate cancer, metastatic or high-risk locally advanced, castration-sensitive 2017.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Rituximab Myasthenia gravis (refractory) 2017.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Heidi Trinkman, PharmD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Rituximab Neuromyelitis optica (relapse prevention) 2017.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Rituximab Pemphigus vulgaris (newly diagnosed) 2017.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Heidi Trinkman, PharmD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Capecitabine Breast cancer (adjuvant therapy) 2017.07 (updated 2019.03) Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Strong A, G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Capecitabine Hepatobiliary cancer (adjuvant therapy) 2017.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Bevacizumab Gliomas (recurrent or progressive (pediatrics) 2017.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Omer Koc, MD

Heidi Trinkman, PharmD

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Bevacizumab Medulloblastoma (relapsed or refractory) 2017.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Nick Link, PharmD, BCOP

Heidi Trinkman, PharmD

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Bevacizumab Solid tumors, refractory (pediatrics) 2017.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Corey Carter, MD

Heidi Trinkman, PharmD

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Lenvatinib Hepatocellular carcinoma (advanced) 2017.11 (updated; see 2018.03) Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Durvalumab Non-small cell lung cancer (unresectable, locally advanced) 2017.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Fluorouracil Glaucoma surgery (adjunctive therapy) 2017.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Alemtuzumab Aplastic anemia, refractory 2017.11 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Mark Holdsworth, PharmD

Heidi Trinkman, PharmD

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Alemtuzumab Hemophagocytic lymphohistiocytosis, refractory 2017.11 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Mark Holdsworth, PharmD

Heidi Trinkman, PharmD

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Irinotecan (conventional) Small cell lung cancer (limited stage) 2017.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Omer Koc, MD

Corey Carter, MD

Nick Link, PharmD, BCOP

Equivocal B, G For the off-label use: 4 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Bevacizumab Diabetic macular edema 2017.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Strong A, G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Irinotecan (conventional) Unknown primary adenocarcinoma 2017.12 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Omer Koc, MD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, Pharm D, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Tamoxifen Mastalgia, severe 2017.12 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Oxaliplatin Neuroblastoma, high-risk, relapsed/refractory (pediatrics) 2017.12 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Nick Link, PharmD, BCOP

Heidi Trinkman, PharmD

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Cladribine T-cell large granular lymphocytic leukemia (refractory) 2017.12 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Polly Kintzel, PharmD, BCOP, BCPS

Jordan Lundberg, PharmD, BCOP
Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Alemtuzumab Mycosis fungoides/Sezary syndrome (advanced) 2018.01 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP

Nick Link, PharmD, BCOP
Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Alemtuzumab T-cell large granular lymphocytic leukemia 2018.01 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS
Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Nilotinib Acute lymphoblastic leukemia, Ph+ 2018.01 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Heidi Trinkman, PharmD
Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Streptozocin Gastrointestinal neuroendocrine tumors 2018.02 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP Polly

Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP
Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Trastuzumab Breast cancer, metastatic, HER2-positive, hormone receptor-positive (in combination with an aromatase inhibitor) 2018.03 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP
Strong A, G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Lenvatinib Hepatocellular carcinoma (advanced) 2018.03 (updated from 2017.11) Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD
Strong A For the updated LOE /Strength of Recommendation: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Ruxolitinib Graft versus host disease (acute or chronic; treatment) 2018.04 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Heidi Trinkman, PharmD
Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Filgrastim Alcoholic hepatitis (severe) 2018.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Jordan Lundberg, PharmD, BCOP
Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Prednisone Multiple myeloma (previously untreated; transplant ineligible) 2018.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP
Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Everolimus Hodgkin lymphoma (relapsed or refractory) 2018.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Omer Koc, MD

Nick Link, PharmD, BCOP

Jordan Lundberg, PharmD, BCOP
Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Everolimus Thymoma and thymic carcinomas (advanced, refractory) 2018.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP
Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Cetuximab Penile cancer (squamous cell, advanced or metastatic) 2018.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Elizabeth Connor, MD

Omer Koc, MD

Nick Link, PharmD, BCOP
Equivocal C For the off-label use: 4 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Methylprednisolone Prostate cancer (metastatic, castration-resistant) 2018.07 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Jordan Lundberg, PharmD, BCOP
Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Dolasetron Chemotherapy-associated nausea and vomiting (high emetic potential) (adults) 2018.08 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Jordan Lundberg, PharmD, BCOP
Strong G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Dolasetron Chemotherapy-associated nausea and vomiting (low emetic potential) (adults) 2018.08 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Jordan Lundberg, PharmD, BCOP
Strong G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Ondansetron Carcinoid syndrome-associated diarrhea (severe, refractory; alternative agent) 2018.08 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Nivolumab Melanoma, metastatic with brain metastases 2018.09 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP

Elizabeth Connor, MD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Ipilimumab Melanoma, metastatic with brain metastases 2018.09 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP

Elizabeth Connor, MD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Paclitaxel (protein bound) Bladder cancer, metastatic, platinum-resistant 2018.09 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Omer Koc, MD

Nick Link, PharmD, BCOP

Jordan Lundberg, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Paclitaxel (protein bound) Cervical cancer, advanced, recurrent or persistent 2018.09 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Elizabeth Connor, MD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Atezolizumab SCLC (extensive stage; first-line therapy) 2018.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Brigatinib Non-small cell lung cancer, advanced, (initial ALK-inhibitor therapy) 2018.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Ramucirumab Hepatocellular carcinoma (advanced, relapsed/refractory) 2018.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Elizabeth Connor, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Pembrolizumab Melanoma, stage III (adjuvant treatment) 2018.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Temozolomide Pediatric CNS tumors (anaplastic astrocytoma, brain stem glioma or medulloblastoma), relapsed or refractory 2018.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Jennifer Thackray, PharmD, BCPPS, BCPS

Heidi Trinkman, PharmD

Mark Holdsworth, PharmD

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Procarbazine CNS tumors, low grade gliomas (in children) 2018.11 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Heidi Trinkman, PharmD

Jennifer Thackray, PharmD, BCPPS, BCPS

Mark Holdsworth, PharmD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Vincristine Hepatoblastoma 2018.11 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Heidi Trinkman, PharmD

Jennifer Thackray, PharmD, BCPPS, BCPS

Mark Holdsworth, PharmD

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Doxorubicin (conventional) Hepatoblastoma (pediatrics) 2018.12 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Jennifer Thackray, PharmD, BCPPS, BCPS

Heidi Trinkman, PharmD

Mark Holdsworth, PharmD

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Cabozantinib Hepatocellular carcinoma (advanced) 2018.12 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Elizabeth Connor, MD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Carfilzomib Multiple myeloma (newly diagnosed) 2019.01 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Trastuzumab Endometrial cancer (uterine serous), advanced or recurrent, HER2-positive 2019.01 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Elizabeth Connor, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Ado-trastuzumab emtansine Breast cancer, early, HER2-positive (adjuvant therapy for residual disease) 2019.02 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Elizabeth Connor, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Zoledronic acid Breast cancer, early stage, adjuvant therapy in postmenopausal females 2019.04 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B,G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Oxaliplatin Pancreatic cancer, potentially curable (adjuvant therapy) 2019.05
(updated 2019.07)
Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Elizabeth Connor, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A, G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Leucovorin calcium Pancreatic cancer, potentially curable (adjuvant therapy) 2019.05
(updated 2019.07)
Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Elizabeth Connor, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A, G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Irinotecan Pancreatic cancer, potentially curable (adjuvant therapy) 2019.05
(updated 2019.07)
Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Elizabeth Connor, MD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Strong A, G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Ibandronate Prostate cancer, metastatic, bone pain (alternative agent) 2019.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, Pharm D

Nick Link, PharmD, BCOP

Jordan Lundberg, PharmD, BCOP

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Vincristine Merkel cell carcinoma 2019.05 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Jordan Lundberg, PharmD, BCOP

Equivocal C For the off-label use: 4 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Venetoclax Mantle cell lymphoma, relapsed/refractory 2019.06 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Polly Kintzel, PharmD, BCOP, BCPS

Jordan Lundberg, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Capecitabine Head and neck cancer, squamous cell (recurrent or metastatic; palliative treatment) 2019.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Jordan Lundberg, PharmD, BCOP

Nick Link, PharmD, BCOP

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Mitomycin Hepatocellular carcinoma (chemoembolization) 2019.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Nick Link, PharmD, BCOP

Jordan Lundberg, PharmD, BCOP

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Olaparib Pancreatic cancer, metastatic, BRCA-mutated (maintenance therapy) 2019.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Angela German, PharmD, BCOP

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Vinblastine Kaposi sarcoma, oral lesions (intralesional) 2019.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Angela German, PharmD, BCOP

Mark Holdsworth, PharmD

Jordan Lundberg, PharmD, BCOP

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Encorafenib Colorectal cancer, metastatic, refractory (RAS wild-type, BRAF V600E-mutant) 2019.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Binimetinib Colorectal cancer, metastatic, refractory (RAS wild-type, BRAF V600E-mutant) 2019.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Cetuximab Colorectal cancer, metastatic, refractory (RAS wild-type, BRAF V600E-mutant) 2019.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Ziv-aflibercept Ascites (malignant; due to malignant ovarian cancer) 2019.08 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Elizabeth Connor, MD

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Chlorambucil Necrobiotic xanthogranuloma 2019.08 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Omer Koc, MD

Nick Link, PharmD, BCOP

Jordan Lundberg, PharmD, BCOP

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Chlorambucil Idiopathic membranous nephropathy 2019.08 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Angela German, PharmD, BCOP

Mark Holdsworth, PharmD

Equivocal B,G For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Pentostatin T-cell large granular lymphocytic leukemia 2019.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Angela German, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Jordan Lundberg, PharmD, BCOP

Equivocal C For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Mesna Prevention of cyclophosphamide-induced hemorrhagic cystitis in patients with rheumatic or autoimmune disorders 2019.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Angela German, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Equivocal C For the off-label use: 4 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Etoposide Hemophagocytic lymphohistiocytosis 2019.12 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Angela German, PharmD, BCOP

Jordan Lundberg, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Pazopanib Desmoid tumors (progressive) 2019.12 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Luspatercept Anemia due to lower-risk myelodysplastic syndromes with ring sideroblasts 2020.01 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Polly Kintzel, PharmD, BCOP, BCPS

Angela German, Pharm D, BCOP

Jordan Lundberg, PharmD, BCOP

Strong A For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Lenalidomide Smoldering myeloma (high-risk) 2020.02 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Angela German, Pharm D, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Regorafenib Osteosarcoma, metastatic, progressive (recurrent, relapsed, or refractory) 2020.02 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Jennifer Thackray, PharmD, BCPPS, BCPS

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Pembrolizumab Breast cancer (triple negative, early stage) 2020.03 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Elizabeth Connor, MD

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Pembrolizumab Mycosis fungoides, Sézary syndrome (relapsed/refractory) 2020.03 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Jordan Lundberg, PharmD, BCOP

Nick Link, PharmD, BCOP

Angela German, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Interferon alfa-2b Essential thrombocythemia (advanced) 2020.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Interferon alfa-2b Myelofibrosis (early) 2020.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Angela German, PharmD, BCOP

Mark Holdsworth, PharmD

Nick Link, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Interferon alfa-2b Polycythemia vera (advanced) 2020.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Daratumumab Systemic light chain amyloidosis (relapsed) 2020.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Angela German, PharmD, BCOP

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Pembrolizumab Malignant pleural mesothelioma, relapsed/refractory, PD-L1 positive 2020.05 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Omer Koc, MD

Equivocal C For the off-label use: 4 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Porfimer Cholangiocarcinoma (unresectable) 2020.06 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP

Equivocal B For the off-label use: 4 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Fam-trastuzumab deruxtecan Gastric cancer, advanced, previously treated (HER2-positive) 2020.07 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest
Paclitaxel (conventional) Anal cancer (advanced) 2020.08 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Angela German, PharmD, BCOP

Omer Koc, MD

Jordan Lundberg, PharmD, BCOP

Equivocal B For the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Off-Label Uses Removed From Database

Monograph Off-Label Use Removed Date Participating Panel Member(s) Strength of Recommendation Off-Label Use Removal Vote Record Conflict of Interest Statement
Ixabepilone Endometrial cancer (second-line treatment) 2014.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Mark Holdsworth, PharmD
Against off-label use: Evidence suggests a lack of support for this off-label use; additional studies are needed to further define the role of ixabepilone in the management of this condition Remove the Off-Label Use: 4 of 5 (add to unsupported use) No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Bevacizumab Ovarian cancer, advanced, recurrent (platinum sensitive) 2014.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP
FDA-approved (no panel vote needed - removed from off-label uses due to approval by FDA) N/A N/A
Alemtuzumab Multiple sclerosis 2014.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP
FDA-approved (no panel vote needed - removed from off-label uses due to approval by FDA) N/A N/A
Medroxyprogesterone injection Renal Carcinoma (labeled use, add to Use: Unsupported) 2015.02 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Cater, MD

Omer Koc, MD

Polly Kintzel, PharmD, BCOP, BCPS
Against Off-Label Use Add to Use: Unsupported: 5 of 5 (add to unsupported use) No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Decitabine Sickle Cell Anemia 2015.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Heidi Trinkman, PharmD
Against off-label use: Evidence suggests a lack of support for this off-label use; evidence-based guidelines do not mention decitabine as a therapeutic option for management of sickle cell anemia. Additional studies are needed to further define the role of decitabine in the management of this condition. Remove the Off-Label Use: 4 of 5 (add to unsupported use) No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Topotecan Merkel cell carcinoma 2015.06 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP

Against off-label use: Limited evidence exists for the use of topotecan in the management of merkel cell carcinoma; additional trials are needed to further define the role of topotecan in the treatment of this condition. Remove the Off-Label Use: 5 of 5 (add to unsupported use) No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Octreotide Meningioma 2015.09 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD
Add to Use: Unsupported: While results from a small study of octreotide LAR for recurrent meningioma demonstrated partial response or stable disease in some patients, subsequent studies in recurrent/progressive meningioma have not demonstrated a benefit. Given the unknown natural history of meningioma, the role of somatostatin analogues in meningioma is unclear. For the Use: 3 of 6 (Off-label use not added [no consensus]); Add to Use: Unsupported No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Pegfilgrastim Prevention of chemotherapy-induced neutropenia in children 2015.12 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed - removed from off-label uses due to pediatric dosing addition to FDA labeling). n/a n/a
Nivolumab Renal cell cancer, clear cell (advanced) 2015.12 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). n/a n/a
Nivolumab Melanoma, unresectable or metastatic (without BRAF mutation), first-line, single-agent therapy 2015.12 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). n/a n/a
Uridine Triacetate Fluorouracil overdose/overexposure 2015.12 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). n/a n/a
Docetaxel Cervical Cancer (recurrent) 2016.02 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Omer Koc, MD

Polly Kintzel, PharmD, BCOP, BCPS
Against off-label use: Evidence suggests a lack of support for this off-label use; additional studies are needed to further define the role of docetaxel in the management of this condition. Remove the off-label use: 3 of 5 (Add to Use: Unsupported) No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Palbociclib Breast cancer, advanced (second-line endocrine-based therapy) 2016.03 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). n/a n/a
Fulvestrant Breast cancer, advanced (second-line endocrine-based therapy) 2016.02 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). n/a n/a
Cabozantinib Renal cell carcinoma, advanced 2016.05 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Ifosfamide Head and neck cancer 2016.09 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP
Against off-label use: Evidence suggests a lack of support for this off-label use; other contemporary therapies have replaced the use of ifosfamide for the treatment of head and neck cancer. Remove the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Ifosfamide Small cell lung cancer 2016.09 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Corey Carter, MD

Omer Koc, MD

Nick Link, PharmD, BCOP
Against off-label use: Evidence suggests a lack of support for this off-label use; other contemporary therapies have replaced the use of ifosfamide for the treatment of small cell lung cancer. Remove the off-label use: 5 of 5 (Add to Use: Unsupported) No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Nivolumab Head and neck cancer, squamous cell (recurrent or metastatic) 2016.11 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). n/a n/a
Mitomycin Non-small cell lung cancer 2016.11 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP
Against off-label use: Evidence suggests a lack of support for this off-label use; other contemporary therapies have replaced the use of mitomycin for the treatment of non-small cell lung cancer. Remove the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Fluorouracil Thymic cancers 2017.01 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD. BCOP
Against off-label use: A lack of evidence suggests a lack of support for this off-label use. Remove the off-label use: 5 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Antithymocyte globulin (rabbit;Thymoglobulin) Myelodysplastic syndrome (low risk; non-sideroblastic) 2017.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Corey Carter, MD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD. BCOP
Against off-label use: A lack of evidence for antithymocyte globulin (rabbit; Thymoglobulin) suggests a lack of support for this off-label use. Remove the off-label use: 4 of 5 No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

No conflict of interest

Regorafenib Hepatocellular carcinoma (intermediate or advanced) 2017.05 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). n/a n/a
Pembrolizumab Urothelial carcinoma (advanced) 2017.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). n/a n/a
Dabrafenib Non-small cell lung cancer, metastatic, relapsed or refractory (with BRAF V600E mutation) 2017.07 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). n/a n/a
Trametinib Non-small cell lung cancer, metastatic, relapsed or refractory (with BRAF V600E mutation) 2017.07 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). n/a n/a
Tocilizumab Cytokine release syndrome (due to CAR-T cell therapy) 2017.09 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Vemurafenib Erdheim-Chester disease, refractory (with BRAF V600E mutation) 2017.11 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP
FDA approved (no panel vote needed - removed from off-label uses due to approval by FDA). n/a n/a
Busulfan (oral) Chronic myeloid leukemia (palliative treatment) 2017.12 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Heidi Trinkman, PharmD
Against the use: Although palliative treatment of chromic myeloid leukemia (CML) is as an approved use in the manufacturer’s labeling for busulfan tablets, other contemporary therapies have replaced the use of oral busulfan for management of CML. According to the European LeukemiaNet Recommendations for Management of CML, treatments include tyrosine kinase inhibitors, omacetaxine, or allogeneic transplant, however, oral busulfan (unless part of a transplant conditioning regimen) is not recommended (Baccarani 2013). Remove the off-label use: 4 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Cladribine Chronic myeloid leukemia (palliative treatment) 2017.12 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Omer Koc, MD

Polly Kintzel, PharmD, BCOP, BCPS

Jordan Lundberg, PharmD, BCOP
Against off-label use: Evidence suggests a lack of support for this off-label use; other contemporary therapies have replaced the use of cladribine for the treatment of chronic lymphocytic leukemia. Remove the off-label use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Olaparib Breast cancer, metastatic, HER2-negative, BRCA-mutated 2018.01 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Abiraterone Prostate cancer, metastatic or high-risk locally advanced, castration-sensitive 2018.02 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Durvalumab Non-small cell lung cancer (unresectable, locally advanced) 2018.03 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Sargramostim Hematopoietic radiation injury syndrome, acute 2018.04 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Estramustine Prostate cancer (metastatic castration-resistant) 2018.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Nick Link, PharmD, BCOP
While estramustine is approved for palliative treatment of progressive or metastatic prostate cancer, guidelines from the American Society of Clinical Oncology/ Cancer Care Ontario (for systemic therapy in men w/metastatic castration-resistant prostate cancer) recommend against offering estramustine to men with metastatic castration-resistant prostate cancer due to a lack of benefit in survival or quality of life and an increased risk of toxicity (ASCO [Basch 2014]). Remove the use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Rituximab Pemphigus vulgaris (newly diagnosed) 2018.06 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP
FDA approved; (no panel vote needed – removed from off-label uses due to FDA approval) n/a n/a
Cetuximab NSCLC, EGFR-expressing, advanced 2018.07 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Elizabeth Connor, MD

Omer Koc, MD

Nick Link, PharmD, BCOP
American Society of Clinical Oncology (ASCO) guidelines for Systemic Therapy for Stage IV Non-Small Cell Lung Cancer do not recommend cetuximab in the treatment of advanced NSCLC (ASCO [Masters 2015]). Cetuximab does not currently have an established role in the treatment of NSCLC either as a component of initial therapy or as second-line therapy. Remove the off-label use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Vinblastine Breast cancer 2018.07 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Elizabeth Connor, MD

Omer Koc, MD

Nick Link, PharmD, BCOP
Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of vinblastine for the treatment of refractory breast cancer. Remove the use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Nivolumab Small cell lung cancer (progressive) 2018.08 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed – removed from off-label uses due to FDA approval) n/a n/a
Lenvatinib Hepatocellular carcinoma (advanced) 2018.08 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP
FDA approved (no panel vote needed – removed from off-label uses due to FDA approval) n/a n/a
Dactinomycin Osteosarcoma 2018.09 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Jennifer Thackray, PharmD, BCPPS, BCPS

Mark Holdsworth, PharmD

Limited (older) data exists for the use of chemotherapy regimens containing dactinomycin in the treatment of non-metastatic osteosarcoma; other contemporary chemotherapy regimens have replaced the use of dactinomycin-containing regimens for management of osteosarcoma. Remove the off-label use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Mechlorethamine Bronchogenic carcinoma (palliative treatment) 2018.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine in the palliative management of bronchogenic carcinoma. Remove the use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Mechlorethamine Chronic lymphocytic leukemia (palliative treatment) 2018.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Omer Koc, MD

Polly Kintzel, PharmD, BCOP, BCPS

Jordan Lundberg, PharmD, BCOP

Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine in the palliative management of chronic lymphocytic leukemia (CLL). CLL guidelines and treatment recommendations do not include mechlorethamine as a treatment option (ESMO [Eichhorst 2015]; iwCLL [Hallek 2018]). Remove the use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

Mechlorethamine Chronic myelocytic leukemia (palliative treatment) 2018.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Omer Koc, MD

Polly Kintzel, PharmD, BCOP, BCPS

Jordan Lundberg, PharmD, BCOP

Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine injection in the palliative management of chronic myelocytic (myeloid) leukemia (CML). CML guidelines and treatment recommendations do not include mechlorethamine as a treatment option (ELN [Baccarini 2013]; ESMO [Hochhaus 2017]). Remove the use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Mechlorethamine Lymphosarcomas (palliative treatment) 2018.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Nick Link, PharmD, BCOP

Jennifer Thackray, PharmD, BCPPS, BCPS

Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine injection in the palliative management of lymphosarcomas. Remove the use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Mechlorethamine Malignant effusion from metastatic carcinomas (palliative treatment) 2018.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Jennifer Thackray, PharmD, BCPPS, BCPS

Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine injection in the palliative management of malignant effusions. Remove the use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Mechlorethamine Mycosis fungoides (palliative treatment) 2018.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Heidi Trinkman, PharmD

Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of IV mechlorethamine in the palliative management of mycosis fungoides. A topical mechlorethamine product is commercially available and approved for treatment of mycosis fungoides-type cutaneous T-cell lymphoma. Remove the use: 4 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Mechlorethamine Polycythemia vera (palliative treatment) 2018.10 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Omer Koc, MD

Polly Kintzel, PharmD, BCOP, BCPS

Jordan Lundberg, PharmD, BCOP

Although included in the manufacturer's labeling as a use, other contemporary therapies have replaced the use of mechlorethamine injection in the palliative management of polycythemia vera. Chronic myeloproliferative neoplasm guidelines do not include mechlorethamine as a treatment option for polycythemia vera (ESMO [Vannucchi 2015]). Remove the use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Mitoxantrone Breast cancer (metastatic) 2018.12 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Elizabeth Connor, MD

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Limited (older) data exists for the use of mitoxantrone in the treatment of metastatic breast cancer; other contemporary therapies have replaced the use of mitoxantrone for the treatment of metastatic breast cancer. Remove the use: 4 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Pembrolizumab Merkel cell carcinoma (advanced) 2019.01 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Cabozantinib Hepatocellular carcinoma (advanced) 2019.01 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Pembrolizumab Melanoma, stage III (adjuvant treatment) 2019.02 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Atezolizumab Small cell lung cancer (extensive-stage) 2019.03 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Ado-trastuzumab emtansine Breast cancer, early, HER2-positive (adjuvant therapy for residual disease) 2019.05 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Ramucirumab Hepatocellular carcinoma (advanced, relapsed/refractory) 2019.05 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS
FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Vinblastine Melanoma (metastatic) 2019.09 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Angela German, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Although vinblastine has been previously used off-label as a component of the biochemotherapy regimen, CVD-interleukin-interferon (cisplatin, vinblastine, dacarbazine, aldesleukin, and interferon) for the treatment of metastatic melanoma, other contemporary therapies have replaced the use of this regimen in melanoma treatment. While combination biochemotherapy induced higher response rates and progression-free survival, this regimen did not improve overall survival or result in durable responses (Atkins 2008; Ives 2007). Remove the off-label use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Cisplatin Melanoma (metastatic) 2019.09 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Angela German, PharmD, BCOP

Polly Kintzel, PharmD, BCOP, BCPS

Nick Link, PharmD, BCOP

Although cisplatin has been previously used off-label as a component of the biochemotherapy regimen, CVD-interleukin-interferon (cisplatin, vinblastine, dacarbazine, aldesleukin, and interferon) for the treatment of metastatic melanoma, other contemporary therapies have replaced the use of this regimen in melanoma treatment. While combination biochemotherapy induced higher response rates and progression-free survival, this regimen did not improve overall survival or result in durable responses (Atkins 2008; Ives 2007). Remove the off-label use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Olaparib Pancreatic cancer, metastatic, BRCA-mutated (maintenance therapy) 2020.01 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Interferon alfa-2b Renal cell cancer 2020.01 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Mark Holdsworth, PharmD

Polly Kintzel, PharmD, BCOP, BCPS

Omer Koc, MD

Although interferon alfa-2b is included in combination with bevacizumab as a labeled use for bevacizumab (Avastin), other contemporary therapies have replaced the use of interferon in the management of renal cell cancers (RCC). The 2019 Society for Immunotherapy of Cancer (SITC) consensus statement on immunotherapy in the treatment of advanced renal cell carcinoma does not discuss interferons in the management of this condition (SITC [Rini 2019]). Remove the off-label use: 4 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Interferon alfa-2b Multiple myeloma 2020.01 Diedra Bragalone, PharmD, BCOP, BCPS

Stephanie Minich, PharmD, BCOP

Angela German, PharmD, BCOP

Nick Link, PharmD, BCOP

Jordan Lundberg, PharmD, BCOP

Although interferon alfa-2b has been previous used as maintenance therapy for multiple myeloma, other contemporary therapies have replaced the use of interferon in the management of multiple myeloma. Interferon alfa-2b is not included in ASCO/CCO guidelines for the treatment of multiple myeloma (ASCO/CCO [Mikhael 2019]). Remove the off-label use: 5 of 5 No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest

No Conflict of Interest
Luspatercept Anemia due to lower-risk myelodysplastic syndromes with ring sideroblasts 2020.04 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Encorafenib Colorectal cancer, metastatic, refractory (RAS wild-type, BRAF V600E-mutant) 2020.04 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a
Brigatinib Non-small cell lung cancer, advanced (initial ALK-inhibitor therapy) 2020.06 Stephanie Minich, PharmD, BCOP

Diedra Bragalone, PharmD, BCOP, BCPS

FDA approved (no panel vote needed – removed from off-label uses due to approval by FDA). n/a n/a

Last update September 1, 2020