FDA Approves Dostarlimab in Previously Untreated Locally Advanced Rectal Cancer

The FDA granted accelerated approval to dostarlimab for previously untreated stage II/III locally advanced dMMR or MSI-H rectal cancer based on the phase 2 AZUR-1 trial showing that nearly three-quarters of patients avoided surgery, chemotherapy, or radiotherapy. This approval is part of the FDA's National Priority Voucher pilot program and reflects a significant shift in treatment options for this patient group.

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