• REGULATORY

    FDA grants accelerated approval to dostarlimab for MSI-H/dMMR locally advanced rectal cancer

    On October 19, 2026, the FDA granted accelerated approval to dostarlimab for adults with Stage II/III locally advanced rectal cancer that is MSI-H or dMMR. The approval was based on the AZUR-1 trial in 154 patients who received dostarlimab 500 mg intravenously every 3 weeks for nine cycles. Of 116 ICR-evaluable patients, the sustained clinical complete response rate at 12 months (cCR12) was 47% (95% CI: 27%, 56%); 44 patients (38%) had near CR. (FDA D.I.S.C.O.)