Nuvation gets China NMPA approval for taletrectinib for ROS1-positive NSCLC

Nuvation Bio (NUVB) announced that China’s National Medical Products Administration or NMPA has approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive or ROS1+ non-small cell lung cancer or NSCLC who either have or have not been previously treated with ROS1 tyrosine kinase inhibitors or TKI. As part of an exclusive license agreement, Innovent Biologics will commercialize taletrectinib in China under the brand name DOVBLERON . The product was officially launched in the territory in January 2025. Taletrectinib was previously granted Breakthrough Therapy Designation and Priority Review by China’s NMPA. The approval by China’s NMPA was based on data from the pivotal Phase 2 TRUST-I study of taletrectinib in patients in China, which were published in the Journal of Clinical Oncology and presented at the American Society of Clinical Oncology ASCO Annual Meeting in June. ”