FDA accepts NDA for entrectinib for NTRK fusion-positive, locally advanced or metastatic solid tumors.- Genentech/Roche

Genentech, a member of the Roche Group announced that the FDA has accepted the company�s New Drug Applications (NDAs) and granted Priority Review for entrectinib for the treatment of adult and pediatric patients with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumors who have either progressed following prior therapies or as initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic, ROS1-positive non-small cell lung cancer (NSCLC). These NDAs are based on results from the integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, and data from the Phase I/Ib STARTRK-NG study.

The FDA is expected to make a decision on approval by 18 August 2019.