Bristol Myers Squibb announced that the European Medicines Agency (EMA) has confirmed its submission is complete for its marketing authorisation (MA) for repotrectinib. BMS is seeking approval of repotrectinib as a treatment for ROS1 TKI-naïve and pre-treated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pre-treated adult and paediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumours.
On 15 November 2023 the FDA approved BMS’s Augtyro® (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.