The NHS is rolling out a new immunotherapy for patients with advanced anal cancer after the treatment was approved by the National Institute for Health and Care Excellence (NICE), offering a new option for people with a disease that has historically had limited treatment choices.
Retifanlimab, manufactured by Incyte Biosciences, will be available to around 250 patients annually in England whose cancer has spread or returned locally and cannot be removed through surgery.
The decision follows a major clinical trial in which patients receiving retifanlimab alongside chemotherapy lived for an average of 32.8 months, compared with 22.2 months among those receiving chemotherapy alone. This represents an improvement of more than 10 months in average overall survival.
The treatment is the first immunotherapy specifically approved for advanced anal cancer. It works by helping the immune system recognise and attack cancer cells, and will initially be administered alongside standard chemotherapy.
The rollout will be supported by NHS England's Cancer Drugs Fund, which helps eligible patients access promising cancer treatments while further evidence is collected. The approval and funding arrangements have enabled the NHS to make the treatment available shortly after the NICE decision.
Around 1,600 people are diagnosed with anal cancer in the UK each year. Although the disease can often be treated successfully when detected early, options have been more limited for patients whose cancer has spread or returned and cannot be removed surgically.
How does retifanlimab work and who can receive it?
Retifanlimab is an immunotherapy designed to boost the body's immune response against cancer cells. It is administered through an intravenous drip once every four weeks, for up to a year.
It will be offered to adults with advanced anal cancer that has either spread to other parts of the body or returned locally and cannot be treated through surgery.
In the clinical trial, the combination of retifanlimab and chemotherapy extended average overall survival to 32.8 months, compared with 22.2 months with chemotherapy alone. Some patients also experienced longer-lasting responses to treatment.
Professor Peter Johnson, national clinical director for cancer at NHS England, described the approval as one of the most significant advances in decades for people living with advanced anal cancer.
"Access to this life-extending drug is one of the most significant steps in decades for people living with advanced anal cancer – and this treatment can give them precious extra time with their family and loved ones," he said.
He added that the disease had become more common, while new treatment options had remained limited for many years.
What does the approval mean for cancer treatment in England?
The approval follows collaboration between NICE, NHS England and the pharmaceutical industry to accelerate access to new cancer treatments.
Incyte Biosciences said the decision represented an important development for a patient group that had historically seen limited therapeutic advances.
Pete Williams, general manager UKI and head of mid-size markets at Incyte Biosciences, said the company looked forward to continuing to work with the NHS to support access for eligible patients.
David Winterflood, chief executive of the Anal Cancer Foundation, said people affected by the disease and their families faced challenges throughout the cancer journey, from obtaining a timely diagnosis to navigating treatment and life afterwards.
He said the approval added another treatment option for people whose cancer had returned or spread, bringing renewed attention to a disease that had been overlooked for too long.
The rollout also supports the ambitions of England's National Cancer Plan, which aims to improve access to innovative cancer treatments. The Cancer Drugs Fund plays a role in making promising medicines available to eligible patients while additional evidence is gathered.
For people living with advanced anal cancer, the availability of retifanlimab provides a new treatment option in a field where progress has historically been limited.
