FDA Grants Priority Review to GSK's Jemperli for Rectal Cancer, PDUFA Date Set for February 2027

summarizeSummary

GSK's Jemperli received FDA priority review for dMMR/MSI-H locally advanced rectal cancer, with a PDUFA date of February 2027. Positive AZUR-1 data showed sustained clinical complete responses, potentially eliminating the need for chemotherapy, radiation, and surgery for some patients.

check_boxKey Events · Product Development and Regulatory · GSK

• FDA Priority Review Granted

  The FDA accepted the sBLA for Jemperli (dostarlimab) in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer, with a PDUFA action date of February 2027.

• AZUR-1 Trial Met Primary Endpoint

  The registrational phase II AZUR-1 trial (n=154) demonstrated a meaningful and sustained clinical complete response rate for 12 months (cCR12), with no detectable signs of cancer for at least one year in some patients.

• Potential to Eliminate Standard Treatments

  If approved, Jemperli could eliminate or delay the need for chemotherapy, radiation, and surgery for some patients — a substantial improvement over the historical standard of care.

• Expedited Review Pathways

  The application was accepted under Project Orbis for coordinated international regulatory reviews and is eligible for the National Priority Voucher program, which could result in an earlier FDA decision.

auto_awesomeAnalysis · GSK · Life Sciences

The FDA has accepted GSK's Jemperli (dostarlimab) for priority review in dMMR/MSI-H locally advanced rectal cancer, with a PDUFA action date of February 2027. In the AZUR-1 trial, a meaningful and sustained clinical complete response rate at 12 months was observed, meaning some patients had no detectable signs of cancer for at least a year without chemotherapy, radiation, or surgery. If approved, Jemperli would be the first immunotherapy capable of eliminating or delaying these standard treatments for this patient population. The application is also under Project Orbis for coordinated international reviews and eligible for the National Priority Voucher program, which could accelerate the FDA decision. This expands Jemperli's oncology franchise into a new tumor type with significant unmet need.