# Talimogene laherparepvec

Talimogene laherparepvec (Imlygic, Amgen Europe B.V.) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Melanoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Advanced | Unresectable; Stage IIIB, IIIC and IVM1a; no bone, brain, lung or other visceral disease |

## Products

### Imlygic

- Company: Amgen Europe B.V.
- Target: Oncolytic viral immunotherapy
- Class: Other antineoplastic agents
- ATC: L01XX51
- EU approval: 16 Dec 2015
- Label revised: 6 Jan 2026
- Status: advanced therapy
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/imlygic-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/imlygic-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/imlygic

Mechanism (SmPC section 5.1): Selectively replicates within tumour cells to cause lysis and release of tumour antigens, while expressing human GM-CSF to promote a systemic anti-tumour immune response.

## Label wording

- **Talimogene laherparepvec** (Imlygic), Melanoma, advanced: “Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imlygic-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/talimogene-laherparepvec