GSK Anti-PD-1 Antibody Dostarlimab Wins FDA Accelerated Approval for Locally Advanced MSI-H/dMMR Rectal Cancer

GSK announced that the FDA has granted accelerated approval to its anti-PD-1 antibody dostarlimab for adults with stage II and III MSI-H/dMMR locally advanced rectal cancer. The company described it as the first immunotherapy approved in the United States for this population. The approval is based on data from the phase 2 AZUR-1 trial. Dostarlimab generated global sales of $1.136 billion in 2025.