INCY News & Events

Incyte "announced that the European Commission has approved Zynyz in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal. The EC decision follows the January 2026 positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use. 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. This approval is based on data from the Phase 3 POD1UM-303/InterAACT2 trial evaluating Zynyz or placebo in combination with platinum-based chemotherapy in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy."

Eli Lilly and Company (LLY) and Incyte (INCY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Olumiant for the treatment of adolescents with severe alopecia areata. AA is a chronic immune disease that can have an especially devastating social and emotional impact on young patients and their families, as early onset AA can be more severe and lead to extensive and unpredictable hair loss. Lilly has also submitted Olumiant in the U.S. for approval to treat severe AA in adolescents, with a decision expected in the second half of 2026.

Knight Therapeutics announced that its Brazilian affiliate, United Medical, has submitted a marketing authorization application to ANVISA, the Brazilian health regulatory agency, for NIKTIMVO for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients 6 years and older. On August 4, 2025, Knight announced that it expanded its existing relationship and amended its agreement with Incyte for the exclusive rights to distribute retifanlimab and axatilimab in Latin America. Under the terms of the amended agreement, Incyte will be responsible for the development, manufacture and supply to Knight of retifanlimab and axatilimab, and Knight will be responsible for seeking the necessary regulatory approvals and distributing both medicines in Latin America. Knight and Incyte had entered into an exclusive supply and distribution agreement for tafasitamab and pemigatinib in Latin America in September 2021.