Posted by Michael Wonder on 03 Jan 2025
Innovent announces second new drug pplication of Dovbleron (taletrectinib adipate capsule, ROS1 inhibitor) was approved by China's National Medical Products Administration
2 January 2025 - Innovent Biologics today announced that China's National Medical Products Administration has approved the second new drug application of Dovbleron (taletrectinib adipate capsules), a next-generation ROS1 tyrosine kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1 positive non-small cell lung cancer.
The approval is based on positive results from the pivotal Phase 2 TRUST-I trial (NCT04395677), a multi-center, open-label, single-arm trial that evaluated the safety, tolerability and efficiency of taletrectinib in Chinese patients with advanced ROS1 positive non-small cell lung cancer.
