GSK (LSE:GSK) has secured priority review from the US Food and Drug Administration for Jemperli (dostarlimab) in previously untreated stage II and III mismatch repair deficient (dMMR) and microsatellite instability-high (MSI-H) locally advanced rectal cancer.
The FDA has set a PDUFA action date of February 2027, and the application also qualifies for the agency's National Priority Voucher program, which could bring an earlier decision.
Rectal cancer affects roughly 770,000 people globally each year, with the dMMR/MSI-H subtype accounting for an estimated 5-10% of cases.
Standard treatment, comprising chemotherapy, radiation and surgery, can carry lasting effects on bowel, urinary and sexual function alongside fertility.
If approved, Jemperli could allow some patients to avoid that regimen entirely.
The submission rests on the phase II AZUR-1 trial, which met its primary goal of a sustained clinical complete response at 12 months, meaning no detectable cancer signs for at least a year.
Interim safety data were consistent with dostarlimab's established profile across solid tumours, and full results are due for presentation at a scientific congress later in 2026.
The application was accepted under Project Orbis, the FDA's framework for coordinating reviews with international regulators, though each country retains an independent decision.
Dostarlimab previously received Fast Track and Breakthrough Therapy designations in this setting.
News Intelligence what this means for the company
The AZUR-1 trial met its 12-month clinical complete response endpoint, and the FDA's priority review with a February 2027 decision date signals regulatory confidence in dostarlimab for a treatment-naive rectal cancer subset. If approved, the drug could spare dMMR/MSI-H patients (5–10% of the ~770,000 annual rectal cancer cases globally) from chemotherapy, radiation and surgery—a meaningful clinical advance that addresses a genuine unmet need in a population facing lasting bowel, urinary and sexual dysfunction from standard care.
This is a label expansion for an already-approved oncology asset with established commercial traction across endometrial indications. The rectal cancer opportunity is narrowly defined by biomarker (dMMR/MSI-H) and stage, but approval would diversify dostarlimab's revenue base and reinforce GSK's oncology portfolio at a time when the company is integrating the Nuvalent lung cancer acquisition and managing mixed signals across its broader pipeline.
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