Genentech announced that the U.S. Food and Drug Administration (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 August 18, 2019.
“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, M.D., chief medical officer and head of Global Product Development. “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.”
The FDA grants Priority Review to medicines determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease. Entrectinib was also granted Breakthrough Therapy Designation (BTD) by the FDA in May 2017 for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or have no acceptable standard therapies. BTD is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible.
Genentech is leveraging its expertise in developing personalized medicines and advanced diagnostics, in conjunction with Foundation Medicine, to develop a companion diagnostic that will help identify people with ROS1 and NTRK gene fusions.