MHRA approves Retifanlimab (ZYNYZ) for the treatment of advanced anal cancer

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), a type of anal cancer that cannot be removed by surgery and is metastatic or has come back in the same area as the original cancer.

The MHRA previously approved retifanlimab on July 6, 2026 for the treatment of adults with advanced Merkel cell carcinoma (MCC) - a rare, aggressive type of skin cancer.

Retifanlimab is used in combination with carboplatin and paclitaxel, which are chemotherapy medicines, and works by helping the body's immune system recognise and attack cancer cells. It blocks a pathway that cancer cells can use to avoid being detected by the immune system, allowing immune cells to better identify and destroy them.

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.

"As with all medicines, we will continue to closely monitor the safety and effectiveness of retifanlimab as it is used more widely."

Retifanlimab is administered via intravenous infusion over around 30 minutes, once every four weeks. For the first six treatment cycles, it is given together with carboplatin and paclitaxel.

In a study of 308 people with metastatic or locally advanced squamous cell carcinoma of the anal canal, retifanlimab given with chemotherapy was more effective than placebo given with chemotherapy, at increasing the amount of time people lived without their cancer getting worse.

For the full list of all side effects reported with this medicine, see Section 4 of the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC) available on the MHRA website.

Notes to editors

• The approval was granted on 5 November 2026 to Incyte Biosciences UK Ltd.

• This product was submitted and approved via International Recognition Procedure (IRP).

• More information can be found in the Summary of Product Characteristics and Patient Information Leaflets which will be published on the MHRA Products website within 7 days of approval.

• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

• The MHRA is an executive agency of the Department of Health and Social Care.

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