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Zynyz (RETIFANLIMAB)
Zynyz works by blocking the PD-1 receptor on immune cells, allowing them to recognize and attack cancer cells.
Zynyz (Retifanlimab) is a programmed death receptor-1 blocking antibody developed by Incyte Corp, targeting programmed cell death protein 1. It is a monoclonal antibody that works by blocking the PD-1 receptor, allowing the immune system to attack cancer cells. Zynyz is FDA-approved for the treatment of Merkel cell carcinoma and is currently patented by Incyte Corp. Key safety considerations include immune-mediated adverse reactions and potential liver damage. As a relatively new medication, there is limited long-term safety data available.
At a glance
| Generic name | RETIFANLIMAB |
|---|---|
| Sponsor | Incyte Corp |
| Drug class | Programmed Death Receptor-1 Blocking Antibody [EPC] |
| Target | Programmed cell death protein 1 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors, and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors.Retifanlimab-dlwr binds to the PD-1 receptor, blocks interaction with its ligands PD-L1 and PD-L2, and potentiates T-cell activity.
Approved indications
- Merkel cell carcinoma
Common side effects
- Fatigue
- Musculoskeletal pain
- Pruritus
- Diarrhea
- Rash
- Pyrexia
- Nausea
- Serious adverse reactions
- Arrhythmia
- Pneumonitis
- Permanent discontinuation of ZYNYZ
- Dosage interruptions
Key clinical trials
- Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (PHASE2)
- Combination Study of SV-BR-1-GM With Retifanlimab (PHASE1,PHASE2)
- A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors (PHASE1,PHASE2)
- Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy (PHASE1)
- ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1 (PHASE1,PHASE2)
- A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation (PHASE1)
- Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas (PHASE1,PHASE2)
- Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |