larotrectinib wins a pioneering FDA approval

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Loxo Oncology's Larotrectinib has won a first-of-its-kind approval from the Food and Drug Administration on Monday, a cancer drug that can treat an array of tumors regardless of where they are in the body. But upending regulatory tradition may have been the easy part, as Loxo’s hopes of making money depend on scouring the world for patients with a rare genetic mutation.

The drug, larotrectinib, is designed to kill off tumors by attacking a protein called TRK, which becomes hyperactive in people with certain genetic mutations. Whereas nearly all cancer drugs are approved to fight malignancies in the lung, breast, or pancreas, Loxo’s therapy is cleared for any advanced cancer that expresses TRK, making it the first drug developed as a tumor-agnostic treatment, according to the FDA.

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