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FDA grants accelerated approval for GSK's JEMPERLI (dostarlimab-gxly) for women with recurrent or advanced 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).  ....

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Endometrial Cancer Survivor Nefa-Tari Moore Shares Her Story


It was August of 2013, and 33-year-old Nefa-Tari Moore had been having a pretty good year. She was working as a licensed practical nurse (LPN) in Brooklyn, NY, and had just gotten married in July. When she started experiencing heavy vaginal bleeding and lower back pain, Moore didn’t think much of it at first until one day in November when her pain really escalated. “That morning, I was too weak to get out of bed,” she recalls. “That’s when I decided to [hop in a cab and] go to the emergency room.”
But even at the hospital, she knew the answers she was getting didn’t tell the full story. “I was told by the doctors that the bleeding may just be a change of menstrual cycles, me being stressed, or that it was all in my head,” Moore says. “They wanted to give me ibuprofen and recommended that I go home and rest.” But she insisted on staying for further observation. Thanks to her persistence, the ER staff set her up with an OB/GYN referral, which ultimately le ....

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