World PostFirst NICE-recommended drug for anal cancer that has spread and cannot be removed through surgery recommended today and is available immediately on the NHS. Hundreds of people could have their lives transformed after NICE today (Thursday, 12 November), for the first time, recommended a new targeted treatment for anal cancer. Retifanlimab, also known as Zynyz and made by Incyte Biosciences, is recommended with platinum-based chemotherapy for adults with anal canal cancer that has spread and cannot be removed through surgery.
It is estimated around 250 people in England could benefit from this new treatment; the first time NICE has recommended a drug to treat this specific form of cancer. The treatment is available in the NHS from today. NICE has published final draft guidance on retifanlimab at the same time that the drug has been granted marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA).
NICE is publishing guidance 30% faster for medicines and 9% faster for healthtech than before April 2024, following changes made through our transformation programme. Anal canal cancer is a rare disease that affects the end portion of the large bowel. Symptoms can include rectal bleeding, pain or severe itching around the anal area and bowel habit changes.
Retifanlimab is given by intravenous (IV) infusion once a month. It works by targeting the programmed death receptor-1 (PD-1) found on the surface of some white blood cells known T-cells, effectively ‘releasing the brakes’ on the immune system to help it recognise and attack cancer cells. The usual treatment for untreated metastatic or inoperable locally recurrent squamous cell anal canal cancer is chemotherapy, specifically carboplatin plus paclitaxel.
Clinical trial evidence shows that retifanlimab plus carboplatin and paclitaxel increases how long people have before their cancer gets worse, and how long they live. The trials found that people taking retifanlimab alongside chemotherapy had an average of 9.3 months where the disease did not progress, compared to a median of 7.4 months for people taking a placebo and chemotherapy. In trials, patients receiving retifanlimab alongside chemotherapy had an average survival length of almost three years (32.8 months), compared to 22.2 months with chemotherapy alone, with some patients experiencing much longer-lasting responses to treatment.
There were an estimated 1,600 new diagnoses of anal cancer each year in the UK from 2017 to 2019, of which two-thirds were in women. Key risk factors include human papillomavirus (HPV) infection, which is linked to about 90% of UK cases, and HIV infection. Treatment options are limited and the outcomes for those with anal cancer that has spread are poor, with only around 20% of people living for five years compared with around 90% in cases where the cancer has not spread.
Patient experts also told NICE’s independent committee there is a lack of wider awareness of anal cancer and its symptoms, meaning it is often diagnosed at a late stage when the cancer has already spread. Helen Knight, director of medicines evaluation at NICE, said: “Anal cancer is a devastating disease with limited treatments so I’m pleased we can recommend this effective, life-extending drug that offers renewed hope to hundreds of people. “Having a medicine available that is shown to help people live longer and improve their quality of life can make a huge difference, giving them more precious time with family and friends.
"We are determined to ensure NHS patients in England have access to the most promising new treatments while providing value for the taxpayer." Dr Claire Coughlan, clinical lead at Bowel Cancer UK said: "We’re delighted that NICE have recommended retifanlimab as a treatment option for some advanced anal cancer patients, in combination with platinum-based chemotherapy." This decision expands treatment options and could offer patients precious extra time with their loved ones. We’re grateful to everyone who contributed to this appraisal. Their voices have been vital in helping to shape this welcome decision.
Dr Claire Coughlan, clinical lead at Bowel Cancer UK David Winterflood, CEO of the Anal Cancer Foundation, said: "Individuals and families facing anal cancer encounter challenges at every stage of the journey, from getting a timely diagnosis to navigating treatment and life beyond it. "Today’s approval of the immunotherapy retifanlimab adds a new tool to the treatment arsenal for people whose cancer has returned or spread. "For a cancer that has been overlooked for too long, this advance brings much-needed attention and hope for continued progress." 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.
Professor Peter Johnson, national clinical director for cancer at NHS England Professor Johnson continued: "For a type of cancer which has become more common, and where very few new treatments have been invented, this represents major progress, and NHS fast-tracking access to the drug means eligible patients can start benefiting from it straight away." NICE’s independent appraisal committee were able to apply a severity modifier of 1.2 to this drug. This allows medicines that are used to treat conditions classed as high or medium severity to have a higher threshold at which they can be considered cost-effective. 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.
Associated guidance and resources Final draft guidance for retifanlimab with platinum-based chemotherapy for treating inoperable, locally recurrent or metastatic squamous cell anal canal cancer untreated with systemic chemotherapy
Source: Wired Gov
