Bristol Myers Squibb announces that the EMA has validated its marketing authorization application (MAA) for repotrectinib in locally advanced or metastatic ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors.

If approved, repotrectinib will offer a potentially first-in-class treatment for patients with these diseases in the European Union", emphasizes the US pharmaceutical company.

This application was based on data from the TRIDENT-1 and CARE registration trials showing robust responses and durable activity. Its validation launches the centralized review procedure of the EMA (European Medicines Agency).

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