GSK Receives the EMA’s CHMP Positive Opinion of Jemperli (dostarlimab) for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer
- The EMA’s CHMP has adopted a positive opinion recommending approval of Jemperli + carboplatin-paclitaxel for adult patients with dMMR/MSI-H primary advanced or recurrent EC. The EC’s decision is expected at the end of 2023
- The opinion was based on interim analysis results from Part 1 of the P-III trial (RUBY/ENGOT-EN6/GOG3031/NSGO) evaluating dostarlimab + carboplatin-paclitaxel vs carboplatin-paclitaxel + PBO. Part 1 of the trial met its 1EPs of investigator-assessed PFS & showed a 72% reduction in risk of disease progression or death
- The results were presented at ESMO and SGO 2023, and published in the NEJM. If dostarlimab is approved, it will become 1st new frontline treatment option in the EU & the immuno-oncology combination regimen available for a patient population
Ref: GSK | Image: GSK
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