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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 , Mismatch Repair Deficient , Microsatellite Instability High , Ruby Study , Ruby Engot Eng Gog3031 Nsgo , New England Journal Of Medicine ,

EMA Validates Type II Variation Application for Dostarlimab/Chemo for dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer

The European Medicines Agency has validated a type II variation for potential approval of dostarlimab in combination with carboplatin and paclitaxel for the treatment of patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer. ....

Hesham Abdullah , European Medicines Agency , Committee For Medicinal Products Human , Medicinal Products , Human Use , New England Journal , Medicines Agency , Endometrial Cancer , Msi H , Ruby Trial ,