Quick answers
- What is Cemiplimab-rwlc used for?
- The FDA-approved label (Libtayo, Regeneron Pharmaceuticals, Inc., August 31, 2026) says: “LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cemiplimab-rwlc have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cemiplimab-rwlc?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cemiplimab-rwlc been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started July 28, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Cemiplimab-rwlc?
- 1 company lists prescription products of Cemiplimab-rwlc in the FDA NDC Directory, including Regeneron Pharmaceuticals, Inc..
What Cemiplimab-rwlc is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. …
— FDA label: Libtayo, Regeneron Pharmaceuticals, Inc., effective August 31, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Libtayo |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Regeneron Pharmaceuticals, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761097 LIBTAYO | Regeneron Pharmaceuticals | September 28, 2018 | 15, latest August 31, 2026 2026: Labeling · 2025: Efficacy · 2025: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 28, 2026 · Class II · Ongoing · D-0767-2026
Lack of Assurance of Sterility
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regener — Regeneron Pharmaceuticals Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 2058830, 2058835 |
|---|---|
| SPL set ID of the quoted label | 4347ae1f-d397-4f18-8b70-03897e1c054a |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761097 |
| Active ingredients (FDA) | CEMIPLIMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Libtayo, Regeneron Pharmaceuticals, Inc., effective August 31, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →