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Pharmaceuticals / Submissions and Approvals

FDA Approves First Cancer Drug for Specific Genetic Mutation

Dec. 5, 2018
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The FDA granted accelerated approval to Vitrakvi (larotrectinib), the first cancer drug indicated to fight a specific genetic mutation rather than the cancer it causes.

The drug is indicated for treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion.

The approval was based on three clinical trials involving 55 pediatric and adult patients, which demonstrated a 75 percent overall response rate across different types of solid tumors.

“Using our breakthrough therapy designation and accelerated approval processes, we support innovation in precision oncology drug development and the evolution of more targeted and effective treatments for cancer patients,” said FDA Commissioner Scott Gottlieb.

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