US FDA Accepts GSK's Supplemental Application for Rectal Cancer Drug for Priority Review

02:24 AM EDT, 08/24/2026 (MT Newswires) -- GSK (GSK.L) said Monday that the US Food and Drug Administration accepted for priority review its supplemental biologics license application for Jemperli, or dostarlimab, as a treatment for advanced rectal cancer. The application is specific to the administration of the treatment to patients with previously untreated stage II and III mismatch repair deficient locally advanced rectal cancer. The UK-based pharmaceutical company supported the application with results from the phase 2 Azur-1 trial. The Prescription Drug User Fee Act action date was set for February 2027, with a possibility for an earlier decision due to eligibility for expedited review under the National Priority Voucher program.