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FDA Grants Priority Review to Dostarlimab Plus Chemo for dMMR/MSI-H Endometrial Cancer

The FDA has accepted and granted priority review to a supplemental biologics license application seeking the approval of dostarlimab plus chemotherapy for use in adult patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.
New England Journal Dostarlimab Plus Chemotherapy Endometrial Cancer Msi H Gynecologic Cancer Priority Review

Dostarlimab in Combination with Chemotherapy for the Treatment of Primary Advanced or Recurrent Endometrial Cancer: A Placebo-Controlled Randomized Phase 3 Trial (ENGOT-EN6-NSGO/GOG-3031/RUBY)

Mansoor R. Mirza, MD, reviews data from the phase 3 RUBY trial investigating dostarlimab in combination with carboplatin and paclitaxel for the treatment of primary advanced or recurrent endometrial cancer.
Mansoorr Mirza Primary Advanced Recurrent Endometrial Cancer Placebo Controlled Randomized Phase Endometrial Cancer Advanced Endometrial Cancer

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