GSK announced that the US Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in patients with previously untreated stage II and III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for February 2027, the company said, adding that the application is also eligible for expedited review under the National Priority Voucher programme, which could lead to an earlier regulatory decision.
Rectal cancer, a type of bowel cancer, is estimated to affect around 770,000 people worldwide each year, with approximately 5-10 per cent of cases classified as dMMR/MSI-H. Standard treatment typically involves chemotherapy, radiation and surgery. While these approaches can be effective, they may cause lasting effects on bowel, urinary and sexual function, fertility and overall quality of life.
The application is supported by positive results from the registrational Phase II, single-arm AZUR-1 trial. The study demonstrated a meaningful and sustained clinical complete response rate at 12 months (cCR12), with patients showing no detectable signs of cancer for at least one year. GSK plans to present the data at a scientific congress later in 2026.
GSK said that, if approved, dostarlimab could become the first immunotherapy with the potential to eliminate or delay the need for chemotherapy, radiation and surgery in some patients in this population.
Dostarlimab previously received Fast Track and Breakthrough Therapy designations for this indication. The application has also been accepted under Project Orbis, an FDA Oncology Center of Excellence initiative that enables coordinated reviews by international health authorities. Regulatory decisions, however, remain independent in each country.
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody and forms the backbone of GSK’s immuno-oncology research and development programme. Its clinical development programme includes studies evaluating Jemperli alone and in combination with other therapies across gynaecologic, colorectal, head and neck and other cancers.
Jemperli was discovered by AnaptysBio and licensed to TESARO under a collaboration and exclusive licence agreement signed in March 2014. Under the agreement, GSK is responsible for the ongoing research, development, commercialisation and manufacturing of Jemperli.
