CHMP positive for Zynyz (retifanlimab) for the treatment of Merkel cell carcinoma.- Incyte Biosciences.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zynyz, intended for the treatment of Merkel cell carcinoma.
The applicant for this medicinal product is Incyte Biosciences Distribution B.V.
Zynyz will be available as 500 mg concentrate for solution for infusion. The active substance of Zynyz is retifanlimab, an antineoplastic agent (ATC code: L01FF10) that binds to PD 1 (programmed cell death protein 1) receptor, blocks its interaction with its ligands PD L1 and PD L2, and potentiates T-cell response in the tumour microenvironment.
The benefits of Zynyz are its objective response rate and response duration in patients with metastatic or recurrent locally advanced Merkel cell carcinoma not amenable to surgery or radiation.
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