China-based Innovent Biologics, Inc. (HKG: 1801) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its taletrectinib, a second-generation ROS1 tyrosine kinase inhibitor. The drug is now approved for use in treating adult patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed after prior ROS1-TKI therapy.
Positive Results from Phase II TRUST-I Study
The endorsement from the NMPA is based on positive results from the Phase II TRUST-I study, a multi-center, open-label, single-arm study conducted in China. The study evaluated the safety, tolerability, and efficacy of taletrectinib in patients with ROS1 positive NSCLC, demonstrating potential best-in-class efficacy and safety for the drug.
Co-Development and Commercialization Plans
Taletrectinib is co-developed and commercialized by AnHeart Therapeutics Inc., which was acquired by US firm Nuvation Bio Inc. earlier this year. The drug was licensed in June 2021 and is expected to advance to the first-line setting in China soon. A separate market filing for the first-line treatment of ROS1 positive locally advanced or metastatic NSCLC, previously untreated with ROS1 TKI therapy, was accepted for review by the NMPA in March this year with priority review status.-Fineline Info & Tech
