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EU approves GlaxoSmithKline s first anti-PD-1 therapy for endometrial cancer | 23 April 2021
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FDA approves GSK s Jemperli for dMMR endometrial cancer
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LONDON, April 22, 2021 /PRNewswire/ GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company s Biologics License Application. 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. This indication is approved under accelerated approval based on tumor 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(s).
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.