Posted by Michael Wonder on 02 Jan 2024
European Medicines Agency validates Bristol Myers Squibb’s application for repotrectinib for the treatment of locally advanced or metastatic ROS1 positive non-small cell lung cancer and NTRK positive solid tumours
2 January 2024 - Application based on data from the registrational TRIDENT-1 and CARE trials showing robust responses and durable activity in these patient populations.
Bristol Myers Squibb today announced that the EMA has validated its marketing authorisation application for the next generation tyrosine kinase inhibitor (TKI) repotrectinib as a treatment for ROS1 TKI naïve and pretreated adult patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer and TKI naïve and pretreated adult and paediatric patients 12 years and older with NTRK positive locally advanced or metastatic solid tumours.
