Biopharmaceutical company GSK plc (LON:GSK) (NYSE:GSK) announced on Monday that the US Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application for Jemperli (dostarlimab) for previously untreated stage II and III dMMR/MSI-H locally advanced rectal cancer, with a PDUFA action date of February 2027.

The application is supported by phase II AZUR-1 data showing a meaningful and sustained clinical complete response rate, with no detectable signs of cancer for at least 12 months.

If approved, Jemperli could eliminate or delay the need for chemotherapy, radiation and surgery for some patients, potentially representing a significant change from the current standard of care.

The application was accepted under Project Orbis, which supports coordinated regulatory reviews across international health authorities, and is also eligible for expedited review through the National Priority Voucher programme.

GSK said AZUR-1 interim safety and tolerability findings were generally consistent with dostarlimab's established safety profile across solid tumours. The findings build on earlier research conducted with Memorial Sloan Kettering Cancer Center demonstrating clinical complete responses with dostarlimab alone in this patient population.

Dostarlimab previously received Fast Track and Breakthrough Therapy Designations for this setting.

Regulatory decisions under Project Orbis remain independent in each country.