Incyte has announced that the European Commission (EC) has approved Zynyz (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).
Worldwide, SCAC is the most common type of anal cancer, making up 85% of cases. It is a rare disease for which the incidence increases approximately 3% per year, with an estimated prevalence at around one or two cases per 100,000 people. About 90% of cases are associated with human papillomavirus (HPV) infection—the main risk factor for anal cancer. HIV is an important amplifier of anal cancer, as people with HIV are 25 to 35 times more likely to develop it. Anal cancer shares many of the same symptoms as non-cancerous conditions, such as haemorrhoids—including pain, itching, a lump or mass and changes in bowel movements—and as a result can go undetected leading to the majority of patients presenting with locally advanced disease.
“The EC approval of Zynyz marks an important step forward for patients with advanced SCAC, a rare cancer for which meaningful treatment advances have not occurred in several decades,” said Bill Meury, president and CEO of Incyte.
“As the first PD-1 immunotherapy approved in Europe in combination with platinum-based chemotherapy in the first-line setting, Zynyz helps expand the standard-of-care options available to clinicians and underscores our commitment to delivering innovative medicines that can have an impact for patients.”
The EC decision follows the January 2026 positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This marks the second indication in Europe for Zynyz, which was previously approved by the EC as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.
The approval is based on data from the phase 3 POD1UM-303/InterAACT2 trial evaluating Zynyz or placebo in combination with platinum-based chemotherapy (carboplatin and paclitaxel) in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy.
Results from the trial, published in The Lancet, demonstrated a statistically significant 37% reduction in the risk of progression or death. Patients in the Zynyz and chemotherapy combination group achieved a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for patients in the placebo combination group. Clinically meaningful improvement was also demonstrated for all secondary efficacy endpoints, including the key secondary endpoint of overall survival. No new safety signals were identified, and the safety profile was representative of other combinations with PD-1 inhibitors and chemotherapy. Serious adverse reactions occurred in 47% of patients receiving Zynyz in combination with chemotherapy. The most frequent serious adverse reactions were sepsis, pulmonary embolism, diarrhoea and vomiting.