GSK Obtains Accelerated US FDA Approval for Jemperli in Locally Advanced Rectal Cancer

11:19 PM EDT, 10/19/2026 (MT Newswires) -- GSK (GSK.L) secured accelerated approval from the US Food and Drug Administration for Jemperli to treat stage 2 and 3 microsatellite instability-high/mismatch repair deficient, or dMMR or MSI-H, locally advanced rectal cancer in adults. The pharmaceutical company said Monday that the approval was based on the phase 2 Azur-1 trial, in which a "clinically significant" proportion of patients showed sustained clinical complete responses after one year or more of treatment with Jemperli, or dostarlimab. Full results from the interim analysis of Azur-1 will be presented at the European Society for Medical Oncology Congress. GSK previously received the Commissioner's National Priority Voucher, priority review and breakthrough therapy designations for Jemperli in the dMMR or MSI-H locally advanced rectal cancer indication.