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Boost for precision medicine? FDA approves drug targeting different cancers with shared mutation

| | November 29, 2018

The Food and Drug Administration on [November 26] 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.”

The medication, called Vitrakvi, is the second treatment to receive FDA clearance based on a common biomarker found in an array of cancers.

[The] cost will be $32,800 for a 30-day supply of capsules for adults. The cost for the liquid formulation for children will be based on the patient’s surface area but will start at $11,000 per month.

[The drug] 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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The FDA said the efficacy of the drug was studied in three clinical trials involving 55 children and adults. The patients had a 75 percent overall response rate across different types of solid tumors, with almost all the responses lasting six months and 39 percent lasting a year or more.

Read full, original post: FDA approves ‘precision medicine’ drug for different cancers with same mutation

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