The Committee For Medicinal Products For Human Use Of The European Medicines Agency Has Recommended Expanding The Approval Of GSK's Jemperli (Dostarlimab) In Combination With Chemotherapy (Carboplatin And Paclitaxel) For First-line Treatment For Primary Advanced Or Recurrent Endometrial Cancer Who Are Candidates For Systemic Therapy
- Positive opinion based on statistically significant and clinically meaningful progression-free and overall survival data from phase III RUBY trial.
- An expanded approval would include MMRp/MSS tumours, which represent majority of endometrial cancer cases.
- Approval decision expected in Q1 2025.