US FDA accepts priority review for BMS’s Repotrectinib for treatment of ROS1-positive NSCLC

CAR-T Digest - August 2020

May 31, 2023: Repotrectinib (Oral) / NSCLC / BMS: US FDA accepted priority review application

Precigen announced that the US FDA granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2023, for NDA of Repotrectinib for the treatment of ROS1-positive locally advanced or metastatic NSCLC
The approval is based on results from the TRIDENT-1 trial evaluating Repotrectinib (TPX-0005, BMS-986472) in patients with advanced solid tumors
- Repotrectinib demonstrated high response rates and clinically meaningful durability of benefit in both TKI-naïve and TKI-pretreated patients, including those with ROS1 resistance mutations
- The safety profile of Repotrectinib was well-characterized and manageable
“The FDA’s acceptance of this application marks an exciting milestone on our journey to bring this next-generation tyrosine kinase inhibitor to patients. If approved, this would represent a potential best-in-class option for TKI-naïve patients and a potential first-in-class option for patients with ROS1-positive NSCLC who have been previously treated with TKI, and for whom there are currently no approved targeted therapies available…” said Jonathan Cheng, M.D., SVP and head of oncology development, BMS