The U.S. Food and Drug Administration has accepted GSK’s supplemental biologics license application for Jemperli (dostarlimab) under priority review, setting a Prescription Drug User Fee Act (PDUFA) target action date of February 2027.
The filing targets locally advanced rectal cancer in stages II and III with mismatch repair deficiency or microsatellite instability-high (dMMR/MSI-H) status in treatment-naive patients. GSK submitted data from the global, open-label AZUR-1 Phase II study, which enrolled 154 patients. Participants received nine cycles of dostarlimab over six months, administered as 500 mg intravenous infusions every three weeks.
The trial met its primary endpoint, demonstrating a sustained clinical complete response rate for at least 12 months, with no detectable signs of cancer during that period. Full results are slated for presentation at a scientific congress later in 2026.
Jemperli, originally discovered by AnaptysBio and later licensed to TESARO before GSK’s acquisition, is not currently approved for locally advanced rectal cancer anywhere in the world. The application qualifies for expedited review under the FDA’s National Priority Voucher program and was accepted under Project Orbis, enabling coordinated international regulatory assessments while maintaining independent country-level decisions.
Rectal cancer affects approximately 770,000 people globally annually, with an estimated 5% to 10% of cases presenting the dMMR/MSI-H subtype. Standard treatments typically include chemotherapy, radiotherapy, and surgery. Dostarlimab previously received Breakthrough Therapy and Fast Track designations for this indication.
