China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its Augtyro (repotrectinib). The drug is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC) and adult patients with NTRK gene fusion-positive solid tumors.
Drug Profile
Repotrectinib, a next-generation tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers, was licensed by Zai Lab for development and commercialization in Greater China through a deal with Turning Point Therapeutics Inc., which is now a Bristol-Myers Squibb (BMS) company. In November 2023, the drug was approved by the US FDA for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. It subsequently received marketing approval in China in May of last year.-Fineline Info & Tech
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