Bristol Myers’ repotrectinib application validated by EMA

Bristol Myers announced that the European Medicines Agency – EMA – has validated its marketing authorization application for the next-generation tyrosine kinase inhibitor – TKI – repotrectinib as a treatment for ROS1 TKI-naive and -pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer, or NSCLC, and TKI-naive and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on results from the registrational Phase 1/2 TRIDENT-1 trial and CARE study. Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure. In the TRIDENT-1 and CARE trials, repotrectinib demonstrated clinically meaningful response rates in patients across ROS1-positive NSCLC and NTRK-positive solid tumor cohorts. Durability of response was robust and intracranial responses were observed in both settings, as well as in patients whose tumors harbor common resistance mutations. The safety profile of repotrectinib was well characterized and generally manageable with routine standard-of-care treatments. In November 2023 the FDA approved Augtyro – repotrectinib – for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. Turning Point Therapeutics is a wholly owned subsidiary of the Bristol-Myers Squibb Company. As of August 2022, Bristol Myers Squibb acquired the company, including its asset repotrectinib.