NHS Fast-Tracks First Targeted Immunotherapy Treatment for Advanced Anal Cancer - Open Access Government

Retifanlimab is now available on the NHS for patients with advanced anal cancer, following an approval from the National Institute for Health and Care Excellence, Open Access Government reported.

The treatment is administered through an intravenous drip once every four weeks for up to 12 months and is initially given alongside standard chemotherapy.

The rollout began on November 12, 2026, making the medicine available to eligible adults in England within a week of the announcement. Funding for the rollout is provided through the Cancer Drugs Fund, which speeds up access to promising new cancer medicines while further evidence is gathered. Around 250 patients a year are expected to be eligible for the therapy, which is manufactured by Incyte Biosciences UK Ltd.

The immunotherapy works by helping the body’s immune system recognize and attack cancer cells, blocking a pathway that cancer cells use to avoid detection. It is approved for adults with squamous cell carcinoma of the anal canal whose cancer has spread to other parts of the body, is metastatic, or has returned in the same area and cannot be removed by surgery.

The rollout follows promising results from a major clinical trial that found patients receiving retifanlimab alongside chemotherapy lived significantly longer than those receiving chemotherapy alone. Individuals who received the combined therapy achieved a mean overall survival time of 32.8 months, versus 22.2 months for those treated with chemotherapy alone, marking an average gain exceeding 10 months.

Retifanlimab combined with chemotherapy demonstrated greater efficacy than a placebo combined with chemotherapy in prolonging the period individuals lived without disease progression, based on a trial involving 308 participants suffering from metastatic or locally advanced squamous cell carcinoma of the anal canal.

NHS Fast-Tracks First Targeted Immunotherapy Treatment for Advanced Anal Cancer - Open Access Government — Photo: National Health Executive

The Medicines and Healthcare products Regulatory Agency (MHRA) approved retifanlimab, also known as Zynyz, on November 5, 2026, following a submission via the International Recognition Procedure. Julian Beach, Executive Director, Operations, said: “People living with advanced anal cancer need treatments that have been carefully assessed.”

“This approval provides a new treatment option for adults whose cancer cannot be removed by surgery or has spread to other parts of the body or returned to the same area,” Julian Beach added. “As with all medicines, we will continue to closely monitor the safety and effectiveness of retifanlimab as it is used more widely.”

Cancer national cancer institute vv ycnzesag unsplash — Photo: Healthcare Management Magazine

Around 1,600 people are diagnosed with anal cancer across the UK every year, with incidence rates increasing significantly over recent decades. Although early diagnosis frequently leads to successful management of the illness, therapeutic alternatives have historically been much scarcer for patients with late-stage disease.

Professor Peter Johnson, National Clinical Director for Cancer at NHS England, said: “Access to this life-extending drug is one of the most significant steps in decades for people living with advanced anal cancer – and this treatment can give them precious extra time with their family and loved ones.”

“For a type of cancer which has become more common, and where very few new treatments have been invented, this represents major progress, and NHS fast-tracking access to the drug means eligible patients can start benefiting from it straight away,” Professor Peter Johnson said.

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