GSK Reports the CHMP’s Positive Opinion of Jemperli Plus Chemotherapy for Indication Expansion to Endometrial Cancer
Shots:
- The CHMP has recommended indication expansion of Jemperli + CT (carboplatin & paclitaxel) as a 1L treatment of advanced or recurrent endometrial cancer, incl. MMRp/MSS tumors, with EC’s decision anticipated in Q1’25
- Recommendation was based on the Part 1 of P-III (RUBY) study involving endometrial cancer patients (n=785), assessing Jemperli + CT followed by Jemperli vs PBO & Part 2 investigating Jemperli + CT followed by Jemperli + niraparib vs PBO
- Study achieved its dual 1EPs of PFS & OS benefits in this population; OS data were highlighted at SGO 2024 & published in Annals of Oncology. Jemperli's label in the US was expanded for this indication in Aug 2024
Ref: GSK | Image: GSK
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