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FDA grants accelerated approval for GSK s JEMPERLI (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer

Share this article Share this article 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). 

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