Bayer, Loxo to get FDA priority review for cancer med

Bayer announced that the FDA has accepted the New Drug Application, or NDA, submitted by its collaboration partner Loxo Oncology and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase, or NTRK, gene fusion. The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act. NTRK gene fusions are genetic alterations that result in production of tropomyosin receptor kinase fusion proteins, and lead to the development of tumor growth. Bayer and Loxo Oncology are jointly developing larotrectinib, which is being studied globally for the treatment of patients across a wide range of cancers that harbor an NTRK gene fusion. Bayer plans to submit a Marketing Authorization Application, or MAA, in the European Union in 2018.

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