Prescription medicine
Retifanlimab Brand names: Zynyz
Retifanlimab (Zynyz) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the retifanlimab FDA label on DailyMed (effective May 18, 2026); every retifanlimab label on DailyMed.
Highlights of the record
FDA label of May 18, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZYNYZ 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).
Forms and strengths
- 25 mg/ml
Injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is retifanlimab used for?
From the label: indications and usageZYNYZ 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). ( 1.1 ) 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. ( 1.1 ) Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). […]
FDA pharmacologic class: Programmed Death Receptor-1 Blocking Antibody.
Source: FDA drug label (ZYNYZ), Incyte Corporation, effective May 18, 2026 (SPL set 109648d0-d30a-42fc-8273-39cb1540a751), via openFDA; the full label on DailyMed
What does the patient leaflet for retifanlimab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ZYNYZ?ZYNYZ is a medicine that may treat certain types of cancers by working with your immune system. ZYNYZ can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended. […] These are not all of the signs and symptoms of immune system problems that can happen with ZYNYZ. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath, or swelling of ankles confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight persistent or severe muscle pain or weakness, muscle cramps low red blood cells, bruising Infusion reactions that can sometimes be severe. […]
Source: FDA drug label (ZYNYZ), Incyte Corporation, effective May 18, 2026 (SPL set 109648d0-d30a-42fc-8273-39cb1540a751), via openFDA; the full label on DailyMed
Is there a generic for retifanlimab (Zynyz)?
No generic retifanlimab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the retifanlimab label say about other medicines?
The retifanlimab label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carboplatin | warnings and precautions | ZYNYZ in Combination with Carboplatin and Paclitaxel: Immune-mediated colitis occurred in 10% (16/154) of patients receiving ZYNYZ in combination with carboplatin and paclitaxel, including Grade 4 (0.6%), Grade 3 (2.6%), and Grade 2 (3.2%). |
| Paclitaxel | warnings and precautions | ZYNYZ in Combination with Carboplatin and Paclitaxel: Immune-mediated colitis occurred in 10% (16/154) of patients receiving ZYNYZ in combination with carboplatin and paclitaxel, including Grade 4 (0.6%), Grade 3 (2.6%), and Grade 2 (3.2%). |
| Prednisone | warnings and precautions | In general, if ZYNYZ requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. |
Source: FDA drug label (ZYNYZ), Incyte Corporation, effective May 18, 2026 (SPL set 109648d0-d30a-42fc-8273-39cb1540a751), via openFDA; the full label on DailyMed
What next?
- Other programmed death receptor-1 blocking antibodys
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other