ZYNYZ (retifanlimab-dlwr) · INCYTE CORP
ZYNYZ (retifanlimab-dlwr) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of adult patients with squamous cell carcinoma of the anal canal (SCAC) and Merkel cell carcinoma (MCC). For SCAC, it is used as a first-line treatment in combination with carboplatin and paclitaxel for inoperable locally recurrent or metastatic disease, or as a single agent for patients who have progressed on or are intolerant to platinum-based chemotherapy. It is also indicated as a monotherapy for patients with metastatic or recurrent locally advanced MCC.
How ZYNYZ Works
Retifanlimab-dlwr binds to the PD-1 receptor on T cells, which blocks its interaction with the ligands PD-L1 and PD-L2. Normally, when these ligands bind to the PD-1 receptor, they inhibit T-cell proliferation and cytokine production, allowing some tumors to evade immune surveillance. By blocking this pathway, the drug prevents the inhibition of the immune response and potentiates T-cell activity against tumor cells.
Details
- Status
- Prescription
- First Approved
- 2023-03-22
- Patent Cliff
- 2030
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
ZYNYZ Approval History
What ZYNYZ Treats
2 indicationsZYNYZ is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Squamous Cell Carcinoma of the Anal Canal
- Merkel Cell Carcinoma
ZYNYZ Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
ZYNYZ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZYNYZ's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZYNYZ treats. First-in-class if their pivotal trials read out positive.
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INCYTE CORP's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZYNYZ FDA Label Details
Indications & Usage
FDA Label (PDF)ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Mer...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.