GSK granted FDA priority review for label expansion in cancer drug Jemperli
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GSK (NYSE:GSK) announced Tuesday that the FDA accepted its supplemental Biologics License Application (sBLA) for PD-1 receptor blocker Jemperli granting priority review to expand its label as an earlier line option for patients with endometrial cancer.
With the sBLA, the British drugmaker requests the FDA nod to market Jemperli (dostarlimab) with chemotherapy for adults with a certain form of endometrial cancer.
The cancer type called mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer represents an estimated 20-29% of all endometrial cancers.
Accepting the sBLA, the FDA has issued September 23, 2023, as the Prescription Drug User Fee Act action date for its decision.
Under an FDA initiative called Project Orbis, regulators in Australia, Canada, Switzerland, Singapore, and the U.K. will simultaneously review the sBLA for Jemperli.
Jemperli is currently indicated in the U.S. as a single agent in dMMR recurrent or advanced endometrial cancer in a late-line setting.
Jemperli was discovered by AnaptysBio, Inc. (NASDAQ:ANAB), and GSK (GSK) added it to the portfolio when the pharma giant acquired U.S.-based biotech Tesaro in 2018.