FDA Grants Accelerated Approval to Dostarlimab for Organ Preservation in Untreated Stage II/III MSI-H/dMMR Locally Advanced Rectal Cancer

The FDA has granted accelerated approval to dostarlimab for previously untreated stage II/III MSI-H/dMMR locally advanced rectal cancer. Of 154 patients, 110 no longer required surgery, radiotherapy, or chemotherapy. The approval gives some patients who would otherwise need a permanent stoma an option to avoid surgery, radiotherapy, and chemotherapy.