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MHRA approves retifanlimab for advanced squamous cell carcinoma of the anal canal

🇬🇧 MHRA · Wed 11 Nov 2026

The UK regulator has authorised Incyte's retifanlimab (ZYNYZ) with carboplatin and paclitaxel for adults with inoperable, metastatic or recurrent anal canal cancer, via the International Recognition Procedure.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved retifanlimab (ZYNYZ) for adults with squamous cell carcinoma of the anal canal (SCAC). The indication covers disease that cannot be removed by surgery and is metastatic or has returned in the same area as the original cancer. The approval was granted on 5 November 2026 to Incyte Biosciences UK Ltd and announced on 11 November.

Retifanlimab is given alongside the chemotherapy medicines carboplatin and paclitaxel. According to the MHRA, it helps the immune system recognise and attack cancer cells by blocking a pathway that tumours can use to evade detection. It is administered by intravenous infusion over about 30 minutes, once every four weeks, and is given with carboplatin and paclitaxel for the first six treatment cycles.

The agency cited a study of 308 people with metastatic or locally advanced SCAC. In that trial, retifanlimab plus chemotherapy was more effective than placebo plus chemotherapy at lengthening the time people lived without their cancer getting worse. The MHRA did not give figures for the size of the benefit in its announcement.

This is the second UK approval for the product. The MHRA authorised retifanlimab on 6 July 2026 for adults with advanced Merkel cell carcinoma, a rare and aggressive skin cancer. The latest approval went through the International Recognition Procedure (IRP), which lets the MHRA take account of decisions by certain other regulators.

Julian Beach, Executive Director, Operations, said: "As with all medicines, we will continue to closely monitor the safety and effectiveness of retifanlimab as it is used more widely." The Summary of Product Characteristics and Patient Information Leaflet are due to appear on the MHRA Products website within seven days of approval, and the full list of side effects is in Section 4 of the leaflet.

What it means for your team

  • Marketing authorisation holder Incyte Biosciences UK Ltd is the named licence holder, so UK pharmacovigilance and risk-management arrangements for the new SCAC indication sit with it.
  • The MHRA says it will keep monitoring safety and effectiveness as use widens, so expect post-authorisation safety surveillance to continue for this product.
  • The approval used the International Recognition Procedure, a route relevant to teams planning UK filings that build on decisions from other regulators.
  • The SmPC and PIL should be published on the MHRA Products website within seven days of approval, which regulatory and labelling teams can check for the final UK wording.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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