WebDEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Center for Drug Evaluation and Research ... BLA 761223) pursuant to Section 351(a) of the Public Health Service Act. BLA 761174, Jemperli (dostarlimab-gxly) was submitted on December 19, 2024 and approved on April 22, 2024. BLA WebSep 9, 2024 · Jemperli (dostarlimab for injection) is indicated as: monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite …
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WebFull approval (previously accelerated approval) for dostarlimab-gxly (Jemperli ®; GlaxoSmithKline) to treat endometrial cancer, in collaboration with Australia’s Therapeutic Goods Administration, Health Canada, and Switzerland’s Swissmedic. Reviews are ongoing at the other regulatory agencies WebCanada leadership team Policies Spotlight on Global Outstanding people ... JEMPERLI. Specialty medicines Product information: Jemperli product monograph (PDF - 349 KB) Patient information: Important information for patients (PDF - 152 KB) ... super bowl xv program
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WebFeb 28, 2024 · Jemperli (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody for the treatment of mismatch repair deficient (dMMR) endometrial … WebWhat was approved. Jemperli (dostarlimab) was approved for the following therapeutic use: Jemperli is indicated as monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen. WebJEMPERLI is a prescription medicine used to treat adults with a kind of uterine cancer called endometrial cancer and may be used when: your tumor has been shown by a laboratory test to be mismatch repair deficient (dMMR), and your cancer has returned, or it has spread or cannot be removed by surgery (advanced cancer), and you have received chemotherapy … super bowl xxvi program