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EMA Validates BMS’s MA for repotrectinib

Jan 2, 2024

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.