Quick answers
- What is Talimogene laherparepvec used for?
- The FDA-approved label (Imlygic, Amgen Inc, April 4, 2025) says: “IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use: IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Talimogene laherparepvec 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 Talimogene laherparepvec?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Talimogene laherparepvec been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Talimogene laherparepvec?
- 1 company lists prescription products of Talimogene laherparepvec in the FDA NDC Directory, including Amgen, Inc.
What Talimogene laherparepvec is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use: IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. …
— FDA label: Imlygic, Amgen Inc, effective April 4, 2025. 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.
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, suspension |
|---|---|
| Route | Intralesional |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Imlygic |
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.
- Amgen, Inc2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125518 | — | Date not on file | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1721278, 1721283, 1721287, 1721289 |
|---|---|
| SPL set ID of the quoted label | 64ffb680-ea8c-42fc-9649-9e8c0eb77ddb |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125518 |
| Active ingredients (FDA) | TALIMOGENE LAHERPAREPVEC |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Imlygic, Amgen Inc, effective April 4, 2025; 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 →