Loxo Oncology completes rolling submission to FDA for larotrectinib for the treatment of solid tumors harboring an NTRK gene fusion.

Loxo Oncology, Inc. announced that the company has completed the rolling submission of a New Drug Application (NDA) to the FDA for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.

Loxo Oncology and Bayer are engaged in a collaboration for the development and commercialization of larotrectinib. A Marketing Authorisation Application (MAA) submission by Bayer in the European Union is expected in 2018.