GSK Plc: FDA Grants Approval For Jemperli For Patients With DMMR Recurrent Endometrial Cancer

(RTTNews) - GSK plc (GSK.L, GSK) announced the US FDA granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

Separately, GSK announced the US FDA Oncologic Drugs Advisory Committee voted 8 to 5 in support of the question posed to the committee regarding whether data from two proposed single-arm trials will be sufficient to characterize the benefits and risks of Jemperli in the curative-intent setting for patients with mismatch repair-deficient/microsatellite instability-high locally advanced rectal cancer. In January 2023, the FDA granted dostarlimab-gxly Fast Track designation for the treatment of dMMR/MSI-H locally advanced rectal cancer.

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