LONDON, November 12, 2026 — The National Institute for Health and Care Excellence (NICE) has recommended retifanlimab (Zynyz) with platinum-based chemotherapy for adults with metastatic or inoperable anal canal cancer. The treatment is available on the NHS in England from today.
First Targeted Therapy for This Cancer
This marks the first time NICE has recommended a drug specifically for this form of cancer. Around 250 people in England are estimated to benefit annually. Retifanlimab, made by Incyte Biosciences, is an anti-PD-1 immunotherapy given by monthly intravenous infusion. It works by targeting the programmed death receptor-1 on T-cells, releasing the brakes on the immune system to help it recognise and attack cancer cells.
Clinical Trial Results
In trials, retifanlimab plus carboplatin and paclitaxel achieved a median overall survival of 32.8 months, compared with 22.2 months for chemotherapy alone. Progression-free survival improved to 9.3 months from 7.4 months with placebo plus chemotherapy. The standard treatment previously was carboplatin plus paclitaxel chemotherapy alone.
Disease Context
There are an estimated 1,600 new anal cancer diagnoses annually in the UK, two-thirds in women. HPV infection is linked to about 90% of UK cases; HIV is another key risk factor. Only around 20% of people with metastatic anal cancer live five years, versus 90% for localized disease. Patient experts told NICE’s independent committee that a lack of wider awareness often leads to late-stage diagnosis when the cancer has already spread.
Reactions and Access
Helen Knight, NICE medicines evaluation director, called it an “effective, life-extending drug that offers renewed hope” and said the institute is determined to ensure NHS patients have access to promising treatments while providing value for the taxpayer. Anal Cancer Foundation CEO David Winterflood said the approval brings “much-needed attention and hope” for an overlooked cancer. Bowel Cancer UK clinical lead Dr Claire Coughlan welcomed the new treatment option.
NICE published final draft guidance simultaneously with MHRA marketing authorisation. The company has a commercial arrangement in place through a simple patient access scheme that makes retifanlimab available to the NHS with a confidential discount. Early findings suggest this combination extends survival by roughly ten months. Patients should talk to their doctor about whether this treatment is appropriate for their situation.
Sources
- Hundreds of people set to benefit after green light for life-extending advanced anal cancer treatment
- NHS fast tracks rollout of first ever targeted treatment for anal cancer – Sirona Medical Insourcing
Photo: National Cancer Institute / Unsplash (Unsplash License)
