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GSK: FDA accepts license application for Jemperli

( - GSK announces that the US FDA has accepted the supplemental biologics license application for Jemperli (dostarlimab), in combination with chemotherapy, for the treatment of advanced or recurrent primary endometrial cancer.

If approved in this patient population, Jemperli, in combination with chemotherapy, could represent the first significant advance in first-line treatment in decades for patients with advanced or recurrent primary endometrial cancer.

The FDA has granted priority review to this application. Jemperli has also recently received Breakthrough Therapy designation for this potential new indication.

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