NICE recommends retifanlimab, the first drug it has backed for advanced anal cancer
Around 250 people in England could be eligible for the immunotherapy, which is given alongside chemotherapy and is available on the NHS from Thursday under a confidential price discount.
By Daily Oracles News Team2 min read
The National Institute for Health and Care Excellence (NICE) has recommended retifanlimab for adults in England with squamous cell cancer of the anal canal that has spread, or has come back in the same place and cannot be removed by surgery. It is the first drug NICE has recommended for this form of the cancer, and NHS patients can start receiving it from Thursday 12 November.
Around 250 people in England could benefit, NICE estimates. The decision was issued as final draft guidance on the same timetable as the drug's UK licence, which the Medicines and Healthcare products Regulatory Agency (MHRA) granted on 5 November.
Retifanlimab, sold as Zynyz by Incyte Biosciences, is an immunotherapy. It blocks the PD-1 receptor on T-cells, a type of white blood cell, so the immune system can recognise and attack the cancer. Patients have it as a roughly 30-minute drip once every four weeks, with the chemotherapy drugs carboplatin and paclitaxel added for the first six cycles. Carboplatin and paclitaxel on their own are the current standard treatment. The MHRA also approved retifanlimab in July for advanced Merkel cell carcinoma, a type of skin cancer.
What the trial showed
The MHRA cited a study of 308 people with metastatic or locally advanced disease. According to NICE, those given retifanlimab with chemotherapy went 9.3 months on average before their cancer progressed, compared with 7.4 months for those given a placebo with chemotherapy. Average survival was 32.8 months, against 22.2 months with chemotherapy alone.
Cost and access
The price paid by the NHS is not public. Incyte has a simple patient access scheme with a confidential discount. NICE's committee also applied a severity modifier of 1.2, which allows a higher cost-effectiveness threshold for medicines treating high or medium severity conditions.
The UK had about 1,600 new cases of anal cancer a year between 2017 and 2019, two-thirds of them in women. Human papillomavirus (HPV) is linked to around 90% of cases. About 20% of people whose cancer has spread live for five years, compared with around 90% when it has not.
