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GlaxoSmithKline's Immunotherapy For Endometrial Cancer Wins FDA Approval

GlaxoSmithKline's Immunotherapy For Endometrial Cancer Wins FDA Approval
  • The FDA has granted accelerated approval to GlaxoSmithKline plc's (NYSE: GSK) Jemperli (dostarlimab) for endometrial cancer.
  • The approval covers patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR.
  • Jemperli targets the cellular pathway known as PD-1/PD-L1 (proteins found on the body's immune cells and some cancer cells). Jemperli helps the body's immune system in its fight against cancer cells by blocking this pathway.
  • The safety and efficacy of Jemperli was studied in a single-arm, multi-cohort clinical trial. Of the 71 patients in the Jemperli arm, 42.3% had a complete response (disappearance of tumor) or a partial response (shrinkage of tumor) to treatment with Jemperli. For 93% of responders, the response lasted for six months or more.
  • Price Action: GSK shares are down 1.45% at $37.69 in market hours on the last check Thursday.
  • Related content: Benzinga's Full FDA Calendar

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Posted-In: Briefs Endometrial CancerBiotech News Health Care FDA General

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