GSK's Jemperli approved by US regulator for endometrial cancer
Thu, 22nd Apr 2021 21:06
(Alliance News) - GlaxoSmithKline PLC said Thursday the US Food & Drug Administration has approved Jemperli for for women with recurrent or advanced dMMR endometrial cancer.
Dostarlimab, the medical name for Jemperli, is indicated for the treatment of adult patients with mismatch repair deficient, dMMR, recurrent or advanced endometrial cancer, as determined by an FDA approved test, that have progressed on or following prior treatment with a platinum containing regimen, GSK noted.
It continued: "This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial."