Biopharmaceutical company Nuvation Bio Inc (NYSE: NUVB) announced on Monday that it has received approval from China's National Medical Products Administration (NMPA) for taletrectinib to treat adults with advanced ROS1-positive non-small cell lung cancer (NSCLC), regardless of prior ROS1 tyrosine kinase inhibitor (TKI) treatment. Commercialisation in China, under the brand name DOVBLERON, is managed by Innovent Biologics, following its official launch in January 2025.

Approval is based on the Phase 2 TRUST-I study, demonstrating durable responses and extended progression-free survival. Data were published in the Journal of Clinical Oncology and presented at ASCO in June 2024. Taletrectinib previously received Breakthrough Therapy Designation and Priority Review in China.

The U.S. Food and Drug Administration (FDA) accepted a New Drug Application (NDA) for taletrectinib in December 2024, granting Priority Review with a Prescription Drug User Fee Act (PDUFA) date set for 23 June 2025. Pooled results from the TRUST-I and global TRUST-II studies form the basis of the U.S. NDA. The FDA has also granted Breakthrough Therapy and Orphan Drug Designations for advanced ROS1+ NSCLC.

Taletrectinib, an oral, next-generation ROS1 inhibitor, is designed to target advanced ROS1+ NSCLC, including central nervous system-active disease. The drug addresses a critical unmet need for effective, tolerable therapies, as ROS1+ NSCLC accounts for 2% of cases, often with significant brain metastasis rates.

Nuvation Bio, founded in 2018 by Dr David Hung, focuses on oncology innovations, with additional pipeline candidates including safusidenib, NUV-1511 and NUV-868.