MHRA approves retifanlimab for adults with advanced anal cancer
On 5 November 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved retifanlimab, sold under the brand name ZYNYZ, for adults with advanced squamous cell carcinoma of the anal canal. The treatment is for cancer that cannot be removed by surgery, has spread to other body parts, or has returned to the original area. In a study involving 308 patients, retifanlimab given alongside chemotherapy helped people live longer without their cancer worsening compared to chemotherapy with a placebo. The medicine works by blocking a pathway that cancer cells use to hide from immune cells. Patients receive it as an intravenous infusion lasting about 30 minutes once every four weeks. For the first six treatment cycles, it is paired with two chemotherapy drugs, carboplatin and paclitaxel. This approval gives patients living with advanced anal cancer a new treatment option approved through the International Recognition Procedure.
What was announced
The Medicines and Healthcare products Regulatory Agency approved retifanlimab, brand name ZYNYZ, on 5 November 2026. The approval was granted to Incyte Biosciences UK Ltd through the International Recognition Procedure.
This decision allows the medicine to be used for adults with squamous cell carcinoma of the anal canal. It is specifically for cases where the cancer cannot be removed by surgery and has spread or returned to the same area.
Patients receive retifanlimab through an intravenous infusion over about 30 minutes once every four weeks. For the first six treatment cycles, doctors give it alongside two chemotherapy drugs, carboplatin and paclitaxel. The agency previously approved retifanlimab on July 6, 2026 to treat adults with advanced Merkel cell carcinoma, a skin cancer.
What it means
Retifanlimab gives adults with advanced anal cancer a new therapy option. The drug stops cancer cells from using a specific pathway to hide from the body's immune system, which lets immune cells find and destroy the cancer cells.
In a clinical trial of 308 people with metastatic or locally advanced anal cancer, adding retifanlimab to chemotherapy worked better than a placebo given with chemotherapy. Patients taking retifanlimab lived longer without their cancer getting worse. Julian Beach, Executive Director of Operations at the MHRA, stated that the agency will continue to monitor the medicine's safety and effectiveness as more patients use it.
What the announcement does not tell us
The announcement does not state how much retifanlimab will cost or whether it will be funded by the NHS. It does not give a date for when patients in the UK can access the drug.
The MHRA did not include specific statistics showing how many additional months patients lived without disease progression during the trial of 308 people. Finally, the statement does not list individual side effects, referring readers to the product's Summary of Product Characteristics and Patient Information Leaflet instead.
How this was written
This analysis was written with AI from the official announcement below, using only facts that announcement states. The quoted wording is gov.uk: Medicines and Healthcare products Regulatory Agency’s own. Always check the original before acting on anything here.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved retifanlimab (ZYNYZ) for the treatment of adults with squamous cell carcinoma of the anal canal (SCAC).
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