Bristol Myers Squibb has announced that the European Medicines Agency (EMA) has validated the marketing authorization application for repotrectinib, a next-generation tyrosine kinase inhibitor (TKI). This application seeks approval for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), both TKI-naïve and -pretreated, and for adult and pediatric patients aged 12 years and older with NTRK-positive locally advanced or metastatic solid tumors, also TKI-naïve and -pretreated. The submission, grounded in data from the registrational Phase 1/2 TRIDENT-1 trial (for adult patients) and CARE study (for pediatric patients), marks the initiation of the EMA's centralized review process by confirming the completeness of the application.
Repotrectinib, as demonstrated in the TRIDENT-1 and CARE trials, exhibited clinically significant response rates in patients with ROS1-positive NSCLC and NTRK-positive solid tumors. The durability of response proved robust, with observed intracranial responses in both patient groups, including those with tumors carrying common resistance mutations. The safety profile of repotrectinib was well-documented and generally manageable with standard-of-care treatments. Ongoing studies are evaluating long-term outcomes and additional endpoints across diverse patient populations with ROS1-positive locally advanced or metastatic NSCLC and NTRK-positive locally advanced or metastatic solid tumors.
Furthermore, in November 2023, the U.S. Food and Drug Administration granted approval for Augtyro™ (repotrectinib) in the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.