FDA Approves Cancer Drug Based on Genetic Mutation

Last week, the Food and Drug Administration (FDA) for the first time approved a cancer drug, larotrectinib (Vitrakvi), based on a genetic mutation rather than type of cancer. The FDA’s approval drew on the findings of three clinical trials comprised of 55 patients, the results of which were compiled and reported in the New England Journal of Medicine by MSK’s Dr. David Hyman, Dr. Alexander Drilon, and collaborators.

The NTRK gene fusion mutation can only be identified through broad genetic tumor testing. While the mutation occurs in less than one percent of solid tumors, it has been identified in dozens of often rare tumor types in adults and children. In the three trials, patients given the drug had a 75% overall response rate.

Learn More:
OncLive
Washington Post
MSK On Cancer blog  

MSK’s Dr. Peter Bach on Drug Economics

Two recent articles in major news outlets feature MSK’s Dr. Peter Bach discussing drug costs.

A Washington Post article considers alternate methods for calculating drug prices, including “value-based pricing.” Dr. Bach comments that such a system would “anchor a drug’s price to its benefit,” but that the benefit would have to be very clearly defined. Later in the article, Dr. Bach states that it is difficult to determine which aspects of drugs should be valued most and thus become factors in both cost and drug development priorities in a value-based pricing system.

A New York Times article takes a historical view of rising drug costs. U.S. drug spending tripled from 1997 to 2007, then plateaued for about six years before rising again. Dr. Bach explains that the more recent price hikes are due in part to a lack of competition for new biologic drugs and quicker FDA approvals for new, expensive pharmaceuticals.

Open Surgery a Better Option for Cervical Cancer

A study published in the New England Journal of Medicine last week compared minimally invasive and open surgeries for early stage cervical cancer. This prospective randomized trial of 631 participants at 33 medical centers found that patients who had open surgery had higher disease-free survival rates (96.5% at 4.5 years) than those who had minimally invasive surgery (86% at 4.5 years). In reporting the study, the New York Times spoke to numerous gynecologic oncologists, many of whom had heard about the results prior to publication and had already begun changing their approaches to cervical cancer treatment. MSK’s Dr. Ginger Gardner said that the hospital is reviewing its surgical results and making case-by-case surgical decisions in consultation with patients.