Posted by Michael Wonder on 16 Nov 2024
Bristol Myers Squibb receives positive CHMP opinion for repotrectinib for the treatment of advanced ROS1 positive non-small cell lung cancer and advanced NTRK positive solid tumours
15 November 2024 - Recommendation based on data from registrational TRIDENT-1 and CARE trials, which demonstrated robust responses and durable activity with repotrectinib in these patient populations.
Bristol Myers Squibb today announced that the CHMP of the EMA 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 paediatric patients 12 years of age and older with advanced solid tumours 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.
