NHS use of Incyte's anal cancer drug Zynyz backed by NICE

Hundreds of patients in England and Wales with anal cancer could soon be eligible for treatment with Incyte's cancer immunotherapy Zynyz, after reimbursement agency NICE recommended NHS use of the drug.

The endorsement of Zynyz (retifanlimab) comes at the same time as the PD-1 inhibitor was approved by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), another example of the parallel assessment of new medicines by the two authorities.

Specifically, the MHRA approved Zynyz as a first- and second-line treatment for adults with advanced squamous cell carcinoma of the anal canal (SCAC), the most common type of anal cancer that cannot be removed by surgery. The drug should be used in combination with carboplatin and paclitaxel chemotherapy, currently the go-to frontline treatment.

In the POD1UM-303 study, which supported MHRA approval, patients treated with Zynyz and chemo had longer progression-free survival and overall survival (OS) compared to chemo and a placebo. Median OS came in at 32.8 months and 22.2 months, respectively.

Anal cancer is a rare disease, with an estimated prevalence of around 1 or 2 cases per 100,000 people, but SCAC accounts for around 85% of all cases. Most are associated with human papillomavirus (HPV) infection, and it is much more common in people with HIV.

It is estimated that around 250 people in England could benefit from Zynyz, the first therapy recommended by NICE to treat this specific form of cancer. It will be made available from today through the Cancer Drugs Fund, with routine commissioning starting within the next 90 days.

"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," said David Winterflood, chief executive of the Anal Cancer Foundation.

"Today's approval of the immunotherapy retifanlimab adds a new tool to the treatment arsenal for people whose cancer has returned or spread," he added. "For a cancer that has been overlooked for too long, this advance brings much-needed attention and hope for continued progress."

Zynyz is also approved by the MHRA as a first-line monotherapy for Merkel cell carcinoma, an aggressive type of skin cancer, although NHS use for this indication has not been recommended by NICE.

The drug has been a modest earner for Incyte overall since it first reached the market in 2023, but approval in SCAC seems to have unlocked its potential, with sales in the first nine months of the year rocketing 333% to $150 million.