GSK Reports EMA’s Validation of MAA for Jemperli (dostarlimab) to Treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer
- The EMA has validated the Type II variation MAA for Jemperli (PD-1-blocking Ab) to treat patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in combination with CT
- The submission was based on the interim results from the two-part P-III trial (RUBY/ENGOT-EN6/GOG3031/NSGO) evaluating dostarlimab + carboplatin-paclitaxel vs PBO + CT. The trial met its 1EPs of investigator-assessed PFS & showed a clinical benefit in the dMMR/MSI-H population
- The safety & tolerability profiles were consistent with the known safety profiles of the individual agents & the results were presented at ESMO Virtual Plenary & the SGO 2023 and published in NEJM. The US regulatory filing review is expected in H1’23, based on the P-III trial results
Ref: GSK | Image: GSK
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 email@example.com.