Incyte has received European Commission approval for Zynyz (retifanlimab) in combination with carboplatin and paclitaxel as a first-line treatment for adults with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal.
Bill Meury, President and Chief Executive Officer at Incyte, said: “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.”
He added that “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 decision follows a positive opinion issued in January 2026 by the European Medicines Agency’s Committee for Medicinal Products for Human Use. It is the second indication for Zynyz in Europe, after its earlier approval as a monotherapy for the first-line treatment of metastatic or recurrent locally advanced Merkel cell carcinoma.
Approval was supported by data from the phase 3 POD1UM-303/InterAACT2 trial, which evaluated Zynyz or placebo alongside platinum-based chemotherapy in adults with metastatic or inoperable locally recurrent SCAC who had not previously received systemic chemotherapy. Results showed a statistically significant 37% reduction in the risk of progression or death.
Patients receiving the Zynyz combination achieved a median progression-free survival of 9.3 months compared with 7.4 months for those given placebo plus chemotherapy. No new safety signals were identified, although serious adverse reactions occurred in 47% of patients receiving the Zynyz combination.
Sheela Rao, Consultant Medical Oncologist at The Royal Marsden National Health Service Foundation Trust and Lead Investigator for POD1UM-303, explained: “For patients with metastatic or inoperable locally recurrent SCAC, first-line care has historically relied on chemotherapy alone, despite the clear need for better outcomes.”
She said: “The approval of Zynyz in combination with carboplatin and paclitaxel is a significant clinical milestone that brings an immunotherapy-based regimen into earlier treatment and offers clinicians in Europe an important new option for patients.”
