Jemperli (dostarlimab) Approved in the U.S. as First and Only Immunotherapy for Adults with MSI-H/dMMR Locally Advanced Rectal Cancer

GSK received FDA approval for Jemperli (dostarlimab) as the first immunotherapy for adults with stage II and III MSI-H/dMMR locally advanced rectal cancer. The AZUR-1 trial showed 68% of patients achieved sustained clinical complete responses at 12 months without surgery, with no disease recurrences reported among responders after median follow-up of over 2 years. The approval could help eligible patients avoid chemotherapy, radiation, and surgery.