Bristol Myers receives positive CHMP opinion for repotrectinib

Bristol Myers (BMY) Squibb announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval for repotrectinib, a next-generation tyrosine kinase inhibitor, as a treatment for adult patients with ROS1-positive advanced non-small cell lung cancer and for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted. The European Commission, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation. The final EC decision is expected in January 2025.