The FDA has granted a priority review designation to a new drug application (NDA) for entrectinib as a treatment for select adult and pediatric patients with NTRK fusion–positive locally advanced or metastatic solid tumors, as well as patients with metastatic ROS1-positive non–small cell lung cancer (NSCLC), according to Genentech, the developer of the multikinase inhibitor.1
For NTRK fusion–positive tumors, entrectinib would be indicated for patients who have either progressed following prior therapies or as initial treatment when no standard acceptable therapies are available. Under the Prescription Drug User Fee Act, the FDA is expected to decide on the application by August 18, 2019.
The NDA is based on findings from an integrated analysis of the phase II STARTRK-2, phase I STARTRK-1, and the phase I ALKA-372-001 trials, which demonstrated a 57.4% overall response rate (ORR) in patients with NTRK fusion–positive solid tumors and a median duration of response (DOR) of 10.4 months.2 The application is also based on results from the phase I/Ib STARTRK-NG study. The trials enrolled patients across 15 countries and 150 clinical trial sites.
“Entrectinib represents a unique approach to cancer treatment that can potentially target a range of hard-to-treat and rare NTRK fusion–positive tumors regardless of their site of origin, as well as treat ROS1-positive non¬–small cell lung cancer,” said Sandra Horning, MD, chief medical officer and head of Global Product Development, Genentech (Roche), the developer of entrectinib. “By combining comprehensive genomic profiling with actionable targeted therapies, like entrectinib, we are advancing our personalized healthcare goal to find the right treatment for each patient. We are working closely with the FDA to make this potential new option available as soon as possible.”