Biopharmaceutical company Bristol Myers Squibb (NYSE:BMY) announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of repotrectinib for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and for adult and paediatric patients aged 12 and older with NTRK-positive advanced solid tumours.

This recommendation was based on data from the TRIDENT-1 and CARE trials, which demonstrated robust response and durable activity with repotrectinib, a next-generation tyrosine kinase inhibitor (TKI).

If approved, repotrectinib has the potential to be a best-in-class treatment for patients with ROS1-positive NSCLC in the European Union.

In November 2023 the US Food and Drug Administration (FDA) approved Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. In June 2024 the FDA approved Augtyro for the treatment of patients with NTRK-positive locally advanced or metastatic solid tumours.