Incyte announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on its antibody‑drug Zynyz (retifanlimab) for first‑line treatment of advanced squamous cell carcinoma of the anal canal (SCAC). The opinion was issued on January 29 2026 and publicly disclosed on January 30.
The positive opinion follows the Phase 3 POD1UM‑303/InterAACT2 trial, which demonstrated a median progression‑free survival of 9.3 months for Zynyz plus chemotherapy versus 7.4 months for placebo, representing a 37 % reduction in the risk of progression or death. In the same study 47 % of patients experienced serious adverse reactions, with sepsis and pulmonary embolism being the most frequent.
Zynyz is already approved in the United States and Japan for SCAC and has EU approval for Merkel cell carcinoma. The CHMP opinion removes a key regulatory hurdle and triggers a review by the Committee for Orphan Medicinal Products, potentially maintaining the orphan designation that offers market exclusivity and pricing advantages.
For Incyte, the approval expands its oncology portfolio beyond Monjuvi and Niktimvo and provides a new revenue stream ahead of the 2028 JAKAFI patent cliff. The company reinvests 44 % of its 2023 revenue into R&D and aims for more than ten high‑impact product launches by 2030, positioning Zynyz as a critical component of that strategy.
Lee Heeson, Executive Vice President and Head of Incyte International, said the opinion “is a step toward addressing the unmet need for patients in Europe with advanced SCAC and could become a new standard of care.” His comments underscore confidence in the pipeline and the company’s diversification plan.
SCAC is a rare disease, accounting for 85 % of anal cancers, and currently has no EU‑approved treatments. Zynyz’s approval would fill a significant unmet need and could capture a sizable patient population, while the orphan status may facilitate reimbursement and pricing negotiations.
The regulatory milestone is expected to offset the anticipated decline in JAKAFI revenue, strengthen Incyte’s oncology pipeline, and support long‑term growth. The company will need to navigate EU pricing and reimbursement, but the orphan designation and the drug’s proven efficacy position it well for market entry.
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