FDA accepts filing for Jemperli + chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer
GSK plc announced the FDA accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer
If approved in this patient population, dostarlimab plus chemotherapy could represent the first meaningful frontline treatment advancement in decades for patients with primary advanced or recurrent endometrial cancer.
The FDA granted Priority Review for this application and assigned a Prescription Drug User Fee Act action date of 23 September 2023.
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