GSK Reports the US FDA Acceptance of sBLA for Jemperli (dostarlimab) to Treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer
- The US FDA has accepted the sBLA for Jemperli to treat adult patients in combination with CT. The US FDA granted Priority Review with an anticipated PDUFA of Sept 2023
- The sBLA was based on the prespecified interim analysis from part 1 of the P-III trial (RUBY/ENGOT-EN6/GOG3031/NSGO) evaluating dostarlimab + carboplatin-paclitaxel vs carboplatin-paclitaxel + PBO. The trial met its 1EPs of investigator-assessed PFS & showed clinical benefit in the dMMR/MSI-H & overall population at a median duration of follow-up of ≥24.8mos.
- The safety profile was consistent with the known safety profiles of the individual agents. The sBLA of dostarlimab will be reviewed by health authorities in the US, Australia, Canada, Switzerland, Singapore & the UK under the Project Orbis
Ref: GSK | Image: GSK
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