FDA Approves First Immunotherapy for Locally Advanced Rectal Cancer

The FDA has approved dostarlimab (Jemperli, GSK) for adults with stage 2 and 3 microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) locally advanced rectal cancer. This marks the first immunotherapy approval for this specific patient population, based on positive results from the AZUR-1 trial where 68% of patients achieved a clinically complete response at 12 months.