Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), a biopharmaceutical company based in China, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Augtyro (repotrectinib). This treatment is intended for adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC). The approval is supported by the pivotal TRIDENT-1 study, an open-label, single-arm, Phase I/II trial that evaluated repotrectinib in both TKI-naïve and TKI-pretreated patients with ROS1-positive NSCLC. The efficacy and safety data from the Chinese subpopulation align with the global population, showing robust response rates and durable clinical activity. Augtyro was generally well tolerated, presenting a manageable safety profile.
Repotrectinib, a next-generation tyrosine kinase inhibitor that targets the ROS1 and NTRK oncogenic drivers, was acquired by Zai Lab for development and commercialization in Greater China through a licensing deal with Turning Point Therapeutics Inc., which is now a part of Bristol Myers Squibb. In November 2023, the drug was granted approval by the US FDA for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.- Flcube.com
