Loxo Edges Closer To Commercial Market With Larotrectinib, But Diagnostic Challenge Persists

Loxo Oncology Inc. is ramping up to become a commercial-stage oncology company with the launch of the TRK inhibitor larotrectinib, which now is likely late this year or early in 2019. The company announced May 29 that US FDA has accepted its new drug application (NDA) for larotrectinib for the treatment of adult and pediatric patients with solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. With priority review granted for the NDA, the agency's target action date is Nov. 26.

An approval would be the first for Loxo and push the Stamford, Conn.-based biopharma into the commercial stage. The firm is partnered on larotrectinib with Bayer AG through a deal unveiled in November under which Loxo gained $400m up front and held onto co-commercialization rights in the US