Retifanlimab

Routes of
administrationIntravenousATC codeLegal statusLegal status IdentifiersCAS NumberDrugBankUNIIKEGGChemical and physical dataFormulaC₆₄₅₆H₉₉₃₄N₁₇₀₂O₂₀₃₂S₄₆Molar mass145381.13 g·mol⁻¹

Retifanlimab, sold under the brand name Zynyz, is an anti-cancer medication used for the treatment of Merkel cell carcinoma.^[1] Retifanlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.^[1]

It was approved for medical use in the United States in March 2023.^{[1][2][3][4][5]}

Medical uses

Retifanlimab is indicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.^[1][2][6]

History

The US Food and Drug Administration (FDA) evaluated the safety and efficacy of retifanlimab based on PODIUM-201 (NCT03599713), an open-label, multiregional, single-arm study evaluating 65 participants with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for advanced disease.^[2]

The FDA granted the application for retifanlimab priority review, fast track, and orphan drug designations.^[2]

Society and culture

Legal status

In February 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zynyz, intended for the treatment of Merkel cell carcinoma.^[7] The applicant for this medicinal product is Incyte Biosciences Distribution B.V.^[7]

Names

Retifanlimab is the international nonproprietary name.^[8]

References

External links

• Clinical trial number NCT03599713 for "A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)" at ClinicalTrials.gov