Europe - EMA validates BMS' repotrectinib MAA in NSCLC

BMS has announced that the EMA has validaed its MAA for repotrectinib as a treatment for ROS1 TKI-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. 

The application was based on results from the registrational Phase 1/2 TRIDENT-1 trial (adult patients with ROS1-positive NSCLC or NTRK-positive solid tumors) and CARE study (pediatric patients with NTRK-positive solid tumors).

As a reminder, it was approaved last year in the US by the FDA 

Reference link: BMS press release