The MHRA approved retifanlimab (ZYNYZ) on 5 November for adults with anal canal squamous cell carcinoma that cannot be removed by surgery, has spread or has returned.
The Medicines and Healthcare products Regulatory Agency said the licence was granted to Incyte Biosciences UK Ltd through the International Recognition Procedure.
The approved use covers a type of anal cancer that is metastatic, or has come back in the same area as the original cancer, and cannot be treated by surgery.
Julian Beach, the MHRA’s Executive Director, Operations, said the decision provides “a new treatment option” for adults whose cancer cannot be removed by surgery, has spread to other parts of the body or has returned to the same area. He added: “As with all medicines, we will continue to closely monitor the safety and effectiveness of retifanlimab as it is used more widely.”
Retifanlimab is given by intravenous infusion over around 30 minutes, once every four weeks. For the first six treatment cycles it is given together with two chemotherapy medicines, carboplatin and paclitaxel.
The regulator’s assessment drew on 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 a placebo given with chemotherapy at increasing the time people lived without their cancer getting worse.
The medicine is an immune therapy. The MHRA said it helps the body’s immune system recognise and attack cancer cells, by blocking a pathway that cancer cells can use to avoid being detected, so that immune cells can better identify and destroy them.
It is the second UK approval for the drug this year. On 6 July the MHRA approved retifanlimab as the first treatment for adults with advanced Merkel cell skin cancer that has spread or returned and cannot be cured with an operation or radiotherapy.
That licence was also granted to Incyte Biosciences UK Ltd.
The Merkel cell decision rested on a study of 101 adults who had not previously received treatment for their advanced disease.
Of those, 53.5 per cent responded to treatment, 16.8 per cent had no detectable signs of cancer afterwards and 36.6 per cent had tumour shrinkage. Among those who responded, the response typically lasted just over two years.
Merkel cell carcinoma is a rare and aggressive skin cancer that develops from Merkel cells, specialised neuroendocrine cells in the top layer of the skin.
The two approvals cover different cancers, and the dosing described for the anal cancer use includes the chemotherapy combination and the four-weekly schedule.
The MHRA said the Summary of Product Characteristics and the Patient Information Leaflets will be published on its Products website within seven days of approval.
The full list of reported side effects is in Section 4 of the leaflet and in the Summary of Product Characteristics.