FDA accepts larotrectinib for priority review
News of positive regulatory development for its larotrectinib – which has been called the biotech firm’s ‘golden goose’ – sent shares of Loxo Oncology (Nasdaq: LOXO) up 2.12% to $169.24 in morning trading.
Loxo Oncology announced that the US Food and Drug Administration has accepted the company’s New Drug Application (NDA) and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRKgene fusion.
The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act (PDUFA).
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