Pharmacogenomics and Targeted Cancer Therapies: A New Resource

Thursday, May 7, 2020

Nadia Z. Haque, PharmD, MHSA, BCPS, FASHP

Kandace Schuft, PharmD

Targeted cancer therapies, also called precision medicine or personalized medicine, involve tailoring therapy to the specific genetic variants present in a tumor.

The Lexicomp® editorial team has created a new set of drug monographs and tools to assist with the use of targeted cancer therapies. Targeted therapy monographs may provide additional curated information beyond what is available in a drug label, including clinical effectiveness data, information on acquired drug resistance, off-label indications, and drug treatment for uncommon gene variants.

Using Pharmacogenomics Content

Targeted therapy information is found within the Lexicomp pharmacogenomics database.

The majority of traditional Lexicomp pharmacogenomic content is what we have classified as germline gene monographs, discussing variants a person is born with, and they have been available within Lexicomp for many years. The new set has content that has been classified as somatic gene monographs, based on variants or mutations deriving from a tumor or like cause.

Like germline monographs, new somatic monographs include the following fields:

  • Testing Recommendations
  • Related Information
  • Evidence Ratings (based on evidence of association and evidence of testing benefit)
  • Management
  • Discussion

Where the new somatic gene monographs differ is that they include a specific section mentioning acquired resistance information that discusses the mechanism(s) by which cancer cells (or other target cells) become resistant to a particular targeted therapy and potentially how this resistance may be overcome.

Another difference is the Off-Label Clinical Data field, which provides the unique resource of discussion of clinical experiences with the drug when it is used in settings beyond the FDA-labeled indications. Targeted therapies are approved for a specific use in patients; they have a specific molecular target. The main intended purpose of this field is to describe use in patients without the variant or expression level for which it is indicated and/or for cancers in sites other than those for which it is indicated.

Here's an example: Osimertinib is a small molecule inhibitor of the epidermal growth factor receptor (EGFR). Patients with advanced non-small cell lung cancer that has an activating mutation in the EGFR gene are likely to have disease response when treated with EGFR inhibitors. Osimertinib is associated with improved survival compared to earlier generation inhibitors. The Lexicomp monograph on osimertinib summarizes the drug's mechanism of action and discusses which EGFR mutations are associated with sensitivity to osimertinib and which are associated with resistance.

These monographs complement other information in Lexicomp related to pharmacogenomics testing (testing that can help guide drug dosing based on information about gene variants that alter drug metabolism).

Targeted therapies continue to grow in the number of approvals each year. Among oncology professionals, such as oncologists, hematologists, and specially trained clinicians, these medications and information regarding their place in treatment are much more well known when compared with other members of healthcare teams. But it may be those who are not oncology specialists who are caring for the patient on a daily basis. We provide information in our somatic monographs to assist both the specialists and the day-to-day caregivers when it comes to managing adverse effects and drug-drug interactions.

The Lexicomp team began making the targeted cancer therapy monographs in the final quarter of 2019, after about a year of development. Our goal is to make 30-40 of these targeted therapy monographs available by the end of 2020. We hope these will fill an increasing need for curated information about cancer genetics and the implications for patient care.

Nadia Z. Haque, PharmD, MHSA, BCPS, FASHP, is a Senior Clinical Content Specialist for Clinical Effectiveness at Wolters Kluwer, Health. She most recently served as Director of the Precision Medicine Program at Henry Ford Health System in Detroit. Dr. Haque is a reviewer for several professional journals, frequently speaks at professional meetings, and is an author of multiple peer-reviewed publications. She received her PharmD from Wayne State University and a master's degree in health services administration from the University of Michigan.

Kandace Schuft, PharmD, is Senior Clinical Content Specialist - Pharmacogenomics for Clinical Effectiveness at Wolters Kluwer, Health. She works with the clinical drug solutions editorial team to critically review and evaluate scientific, clinical, and product literature in order to create and maintain core pharmacology content. She earned her Doctor of Pharmacy and Bachelor of Arts degrees from the University of Minnesota and completed a post-graduate pharmacy practice residency and pharmacogenomics certification program.

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