| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Programmed cell death protein 1 (PD-1) |
| Clinical data | |
| Trade names | Zynyz |
| Other names | AEX-1188, INCMGA-00012, MGA-012, retifanlimab-dlwr |
| AHFS/Drugs.com | Zynyz |
| MedlinePlus | a623017 |
| License data | |
| Routes of administration | Intravenous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6456H9934N1702O2032S46 |
| Molar mass | 145381.13 g·mol−1 |
Retifanlimab, sold under the brand nameZynyz, is ananti-cancer medication used for the treatment ofMerkel cell carcinoma.[2] Retifanlimab is aprogrammed death receptor-1 (PD-1)–blockingmonoclonal antibody.[2]
It was approved for medical use in the United States in March 2023,[4][5][6] and in the European Union in April 2024.[3]
Retifanlimab isindicated for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.[2][4][7][3]
In May 2025, the USFood and Drug Administration (FDA) expanded the indication for retifanlimab to include, when used withcarboplatin andpaclitaxel, thefirst-line treatment of adults with inoperable locally recurrent or metastaticsquamous-cell carcinoma of the anal canal.[8] The FDA also approved retifanlimab, as a single agent, for adults with locally recurrent or metastatic squamous-cell carcinoma of the anal canal with disease progression on or intolerance toplatinum-based chemotherapy.[8]
The USFood and Drug Administration (FDA) prescription label for retifanlimab includes warnings and precautions for severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.[8]
The USFood 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.[4]
The FDA granted the application for retifanlimabpriority review,fast track, andorphan drug designations.[4]
The efficacy of retifanlimab with carboplatin and paclitaxel was evaluated in POD1UM-303/InterAACT 2 (NCT04472429), a randomized, multi-center, double-blind trial in 308 participants with chemotherapy-naïve inoperable locally recurrent or metastatic squamous-cell carcinoma of the anal canal.[8] Participants received carboplatin AUC of 5 on day 1, and paclitaxel 80 mg/m2 on days 1, 8, and 15 for 6 cycles and were randomized (1:1) to receive either retifanlimab 500 mg intravenously every 4 weeks; or placebo intravenously every 4 weeks.[8]
The efficacy of retifanlimab as a single agent was evaluated in POD1UM-202 (NCT03597295), an open-label, multi-center, single-arm trial in 94 participants with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.[8] Participants received retifanlimab 500 mg intravenously every 4 weeks until disease progression, unacceptable toxicity, or up to 24 months.[8]
In February 2024, theCommittee for Medicinal Products for Human Use of theEuropean 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.[3] The applicant for this medicinal product is Incyte Biosciences Distribution B.V.[3] Retifanlimab was authorized for medical use in the European Union in April 2024.[3]
Retifanlimab is theinternational nonproprietary name.[9]
Retifanlimab is sold under the brand name Zynyz.[2][3]
This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain.
