Information on FDA-approved tests for the detection of dMMR status is available at . https://www.fda.gov/companiondiagnostics. Because the effect of prior chemotherapy on test …
JEMPERLI (dostarlimab-gxly) injection, for intravenous use including liver and thyroid function, at baseline and periodically during Initial U.S. Approval: 2021
FDA grants accelerated approval to dostarlimab-gxly for dMMR …
On August 17, 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair …
FDA approves dostarlimab-gxly with chemotherapy for …
On July 31, 2023, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, …
FDA D.I.S.C.O. Burst Edition: FDA approval of Jemperli (dostarlimab ...
On February 9, 2023, the FDA approved dostarlimab-gxly (brand name Jemperli) for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as …
JEMPERLI- dostarlimab injection - DailyMed
2024年8月1日 · JEMPERLI (dostarlimab-gxly) injection is a clear to slightly opalescent, colorless to yellow solution supplied in a carton containing one 500 mg/10 mL (50 mg/mL), single-dose …
JEMPERLI (dostarlimab-gxly) injection, for intravenous use immune-mediated nephritis with renal dysfunction, immune-mediated Initial U.S. Approval: 2021 dermatologic adverse reactions, and …
Dostarlimab - Wikipedia
In February 2023, the FDA approved dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adults with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as …
FDA Grants Breakthrough Therapy Designation to Dostarlimab …
2024年12月18日 · The FDA has granted breakthrough therapy designation to dostarlimab-gxly (Jemperli) for the treatment of patients with locally advanced mismatch repair–deficient …
FDA expands endometrial cancer indication for dostarlimab-gxly
On August 1, 2024, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adult patients...