FDA Approves GSK’s Jemperli for First-Line MSI-High, dMMR Rectal Cancer

AnaptysBio (ANAB) announced FDA approval for GSK's Jemperli (dostarlimab) to treat locally advanced rectal cancer, based on AZUR-1 trial data. The drug showed significant clinical responses, potentially avoiding chemo, radiation, and surgery. GSK will present full data at ESMO Congress 2026. ANAB manages financial collaborations for Jemperli.

The FDA approved GSK's Jemperli for certain rectal cancers, offering a less invasive treatment option. The drug showed efficacy in clinical trials, with 75% of patients avoiding traditional treatments. GSK shares rose 0.32% to $49.67 on the news.

The FDA approved dostarlimab (Jemperli) for stage II/III MSI-H/dMMR locally advanced rectal cancer. The decision was based on AZUR-1 trial results, where 79% of patients responded, and 47% had a sustained complete response. Dostarlimab is marketed by GlaxoSmithKline (GSK).

AnaptysBio (ANAB) rose after partner GSK (GSK) received FDA approval to expand Jemperli's label for treating certain rectal cancers. The drug is now approved for adults with stage II/III MSI-H/dMMR locally advanced rectal cancer, a subset of 5%-10% of rectal cancers. The approval came earlier than the expected February 2027 date.

AnaptysBio (ANAB) and GSK (GSK) announced FDA approval for Jemperli to treat a type of rectal cancer. The approval was granted under the FDA's accelerated pathway, and ANAB's stock price increased following the news.

GSK announced US FDA approval for Jemperli (dostarlimab) to treat a form of locally advanced rectal cancer. The immunotherapy is the first of its kind for this indication, offering an alternative to standard treatments like chemotherapy, radiation, and surgery. GSK shares closed 0.4% lower at 1,854.89 pence on Monday.