Press release
Incyte Announces Positive CHMP Opinion for Zynyz® (retifanlimab) for First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)
Pending the European Commission decision, Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) will be the
About this update from Incyte Corporation
[{"type":"text","content":"\n\nPending the European Commission decision, Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) will be the first PD-1 immunotherapy treatment for patients with advanced squamous cell carcinoma of the anal canal (SCAC) in Europe\n\n\n\n\nGlobally, the prevalence of SCAC is estimated at around 1 or 2 cases per 100,000 people, with a higher incidence in women than in men1,2,3\n\n\n\n\nThe Committee for Medicinal Products for Human Use (CHMP) positive opinion is based on data from the Phase 3 POD1UM-303/InterAACT2 trial which showed patients with advanced SCAC achieved significantly improved progression-free survival with Zynyz in combination with carboplatin and paclitaxel as a first-line treatment4\n\n\n\n MORGES, Switzerland--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).\n\n\n“Today’s positive CHMP opinion is an important step towards addressing the urgent need for new treatment options for patients in Europe with advanced SCAC, a disease which has seen limited innovation for decades,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved, Zynyz in combination with platinum-based chemotherapy has the potential to become a new standard-of-care for patients living with this rare and difficult-to-treat cancer.”\n\n\nThe positive CHMP opinion was based on data from the Phase 3 POD1UM-303/InterAACT2 trial evaluating Zynyz in combination with (platinum-based chemotherapy) in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy.5\n\n\nResults from POD1UM-303/InterAACT2 (NCT04472429) published in The Lancet showed a statistically significant 37% reduction in the risk of progression or death (P=0.0006).4 Patients in the Zynyz and (platinum-based chemotherapy) combination group achieved a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for patients in t...