GSK has announced that the US FDA has accepted for priority review a supplemental Biologics License Application for Jemperli in previously untreated stage II and III dMMR/MSI‑H locally advanced rectal cancer. The agency has set a PDUFA action date of February 2027, and the application is also eligible for expedited assessment through the National Priority Voucher programme.
Rectal cancer affects around 770,000 people globally each year and 5–10% of cases have the dMMR/MSI‑H subtype. Chemotherapy, radiation and surgery remain standard treatments but can lead to lasting effects on bowel, urinary and sexual function, fertility and overall quality of life.
The submission is supported by positive data from the registrational phase 2 AZUR‑1 trial, which met its primary objective by showing a meaningful and sustained clinical complete response rate for 12 months with no detectable signs of cancer for at least one year. Interim findings indicated that the safety and tolerability of dostarlimab were generally consistent with its established profile across solid tumours.
AZUR‑1 results represent a substantial improvement compared with historical standard care. The data support the potential for dostarlimab, if approved, to become the first immunotherapy capable of eliminating or delaying the need for chemotherapy, radiation and surgery for some patients.
These findings build on earlier research conducted with Memorial Sloan Kettering Cancer Center, which first demonstrated the potential for dostarlimab to achieve clinical complete responses without other treatments in dMMR/MSI‑H locally advanced rectal cancer. Dostarlimab has previously received Fast Track and Breakthrough Therapy Designations in this setting.
The application has also been accepted under Project Orbis, an FDA Oncology Center of Excellence initiative enabling coordinated international reviews. Regulatory decisions remain independent in each participating country.
