The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY) registration approval for its next-generation tyrosine kinase inhibitor (TKI) Augtyro (repotrectinib) for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. This decision follows a priority review of Phase I/II trial results, which demonstrated an objective response rate (ORR) of 38% and a median duration of response (mDOR) of 14.8 months in ROS1 TKI-pretreated patients, with increases to 79% and 34.1 months respectively in TKI-naive participants.
Augtyro’s Distinct Advantage and Upcoming Launch
Augtyro is the first next-generation TKI approved for ROS1-positive NSCLC in the US, offering a lower risk of treatment resistance. Bristol Myers Squibb is set to launch the product next month, according to a press release.
Repotrectinib’s Development and Licensing History
Repotrectinib, originally developed by US firm Turning Point Therapeutics Inc., was licensed to China-based Zai Lab (NASDAQ: ZLAB) in a USD 176 million deal in July 2020, granting Zai Lab exclusive development and commercialization rights in Greater China. Bristol Myers Squibb acquired Turning Point for USD 4.1 billion in 2022. In May 2023, repotrectinib was awarded priority review status in China, and the treatment for ROS1-positive locally advanced or metastatic NSCLC was filed one month later.- Flcube.com
