China NMPA granted Priority Review for Zai lab’s Repotrectinib for the treatment of ROS1-positive NSCLC

CAR-T Digest - August 2020

May 18, 2023: Repotrectinib (IV) / ROS1-positive NSCLC / Zai lab: Received Priority Review from China NMPA

Center for Drug Evaluation (CDE) of China’s NMPA granted priority review to Repotrectinib for the treatment of adult patients with metastatic ROS1-positive NSCLC
Previously Repotrectinib was granted three BTDs from the US FDA for ROS1-positive metastatic NSCLC for ROS1 TKI naive patients, ROS1-positive advanced NSCLC treated with one prior line of chemotherapy, and ROS1 TKI and NTRK-positive solid tumors
“The CDE’s decision to grant priority review to repotrectinib underscores repotrectinib as a potential next-generation best-in-class treatment for ROS1-positive NSCLC in both TKI-naïve and pretreated patients in China,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab