FDA Approves New Drug for Several Cancers with the Same Mutation

By admin
January 02, 2019

WASHINGTON, D.C. – The Food and Drug Administration recently approved a drug for a wide range of cancers based on a shared mutation, rather than the tumors’ locations – an advance for the sometimes controversial field of “precision medicine,” according to a Washington Post article from November 26.

The medication, called Vitrakvi, is the second treatment to receive FDA clearance based on a common biomarker found in an array of cancers. The drug, also called larotrectinib, was approved simultaneously for adults and children. Typically, oncology drugs are considered much later for children.

Last year the agency, for the first time, approved an immunotherapy drug for tumors with a specific genetic signature, regardless of where they originated in the body. But that treatment had been cleared for several cancers, including advanced melanoma.

The drug approved recently is for patients with advanced solid tumors containing what’s called an NTRK gene fusion, a hybrid of two genes that can promote uncontrolled cell growth. Cancers of the thyroid, lung, and head and neck, among others, can be caused by the defect. The drug is for patients whose cancer has spread or who would experience severe complications by undergoing surgery and have no satisfactory alternatives.

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