MHRA approves Retifanlimab (ZYNYZ) for the treatment of advanced anal cancer
The UK’s medicines regulator has approved retifanlimab (ZYNYZ) for adults with advanced anal cancer, offering a new immunotherapy option alongside chemotherapy.
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised retifanlimab (ZYNYZ) for adults with squamous cell carcinoma of the anal canal whose cancer has spread or cannot be surgically removed. The treatment combines retifanlimab with chemotherapy drugs carboplatin and paclitaxel to enhance the immune system’s ability to target cancer cells. Retifanlimab works by blocking a pathway cancer cells use to evade detection, allowing immune cells to identify and attack tumours more effectively.
Administered via a 30-minute intravenous infusion every four weeks, retifanlimab is given alongside chemotherapy for the first six treatment cycles. The MHRA states this approach extends the time patients live without disease progression compared to chemotherapy alone, based on a study involving 308 participants with advanced or metastatic anal cancer.
The approval follows a review under the International Recognition Procedure and was granted to Incyte Biosciences UK Ltd on 5 November 2026. The regulator emphasised its ongoing monitoring of the medicine’s safety and effectiveness as it becomes more widely used in clinical practice.
Full details of side effects and administration guidance are available in the Patient Information Leaflet and Summary of Product Characteristics on the MHRA website, which will be published within seven days of approval.