Shots:
- The CHMP has granted positive opinion to repotrectinib for treating ROS1+ advanced NSCLC in adults and NTRK+ advanced solid tumors in patients (≥12yrs.), with the EC’s decision anticipated in Jan 2025
- Opinion was based on P-I/II (TRIDENT-1 & CARE) trials, with TRIDENT-1 assessing repotrectinib in advanced solid tumors (NSCLC and tumors with ROS1 & NTRK fusions), while CARE focuses on pediatric & young adults with ALK, ROS1, or NTRK gene alterations
- Trials showed meaningful response rates in the patients along with strong durable responses and intracranial activity; safety profile was manageable with standard treatments. Study continues to assess long-term outcomes and additional EPs
Ref: BMS | Image: BMS| Press Release
Related News:- InflaRx’s Gohibic (Vilobelimab) Gains the CHMP’s Positive Opinion for the Treatment of ARDS
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