FDA Accepts Loxo Oncology’s New Drug Application for Larotrectinib

Loxo Oncology (LOXO) said pre-market Tuesday that the US Food and Drug Administration has accepted the company’s New Drug Application and granted Priority Review for larotrectinib, an oral and highly selective investigational tropomyosin receptor kinase for treating adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.

The agency has scheduled a target action date of Nov. 26 under the Prescription Drug User Fee Act.

The biotechnology company has partnered with pharmaceutical giant Bayer for the development and commercialization of larotrectinib. Bayer is planning to submit a Marketing Authorization Application in the European Union this year.

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