GSK Receives the EMA’s CHMP Positive Opinion of Jemperli (dostarlimab) for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer
Shots:
- 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
