Photo credits
GSK’s Jemperli gains FDA approval for advanced rectal cancer
GSK’s immunotherapy Jemperli has received accelerated approval for locally advanced rectal cancer, offering a potential alternative to chemotherapy, radiation, and surgery.
21 Oct 2026 0 reads Compiled with AI
#GSK #Jemperli #dostarlimab #rectal cancer #MSI-H #dMMR
On Monday, the U.S. Food and Drug Administration granted accelerated approval to GSK’s antibody drug Jemperli, also called dostarlimab, for adults with locally advanced rectal cancer that shows microsatellite instability‑high (MSI‑H) or mismatch repair deficiency (dMMR). The decision follows evidence that the drug can control cancer without the need for chemotherapy, radiation, or surgery.
Trial Results Support Approval
The approval was based on a Phase 2 AZUR‑1 trial, in which 68% of evaluable patients (98 of 144) achieved a sustained complete response at 12 months, and no disease recurrence was reported among responders after a median follow‑up of more than two years. A separate study at Memorial Sloan Kettering showed that 93% of 50 patients remained cancer‑free at one year.
Jemperli is a PD‑1‑blocking monoclonal antibody that frees immune cells to attack tumor cells. It was first approved by the FDA for endometrial cancer in 2021 and has become GSK’s top‑selling cancer product. The drug was discovered by AnaptysBio, licensed to Tesaro, and later brought under GSK’s umbrella after acquiring Tesaro in 2018.
With this approval, patients who would normally receive intense chemotherapy or surgery may now consider a single‑agent immunotherapy approach. GSK reported about $1.1 billion in sales for Jemperli in 2025 and is exploring its use in other cancers, including colorectal and head‑and‑neck malignancies. The company will submit further data to confirm long‑term benefit.