MHRA approves retifanlimab for advanced anal cancer
Life Sciences
Wednesday, November 11, 2026
- Updated Nov 11, 2026 12:23
The UK medicines regulator has approved retifanlimab (Zynyz), made by Incyte, in combination with chemotherapy for adults with squamous cell carcinoma of the anal canal that cannot be removed by surgery and has spread or returned.
Why it matters: The approval gives UK patients with a cancer that has few systemic options a first immunotherapy combination, and extends retifanlimab beyond the Merkel cell carcinoma approval the regulator granted in July 2026.
Data as of MHRA press release of November 11, 2026, read in full in this run; approval granted on November 5, 2026 to Incyte Biosciences UK Ltd under the International Recognition Procedure. Developing item.
The Medicines and Healthcare products Regulatory Agency has approved retifanlimab (Zynyz) for adults with squamous cell carcinoma of the anal canal that cannot be removed by surgery and is metastatic or has recurred locally. The drug is given by intravenous infusion every four weeks, in combination with carboplatin and paclitaxel for the first six cycles, and works by blocking a pathway cancer cells use to avoid detection by the immune system.
In a study of 308 people with metastatic or locally advanced disease, retifanlimab with chemotherapy increased the time patients lived without their cancer worsening compared with placebo with chemotherapy, the regulator said. The approval, granted on November 5, 2026 to Incyte Biosciences UK Ltd, follows the drug’s UK approval in July 2026 for advanced Merkel cell carcinoma.
Sources
- MHRA approves Retifanlimab (ZYNYZ) for the treatment of advanced anal cancer - Medicines and Healthcare products Regulatory Agency (MHRA) - 2026-11-11