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Talimogene Laherparepvec

Imlygic · ATC code L01XX51

Also known as: Talimogen laherparepvec, Talimojen laherparepvek

Key facts
Active substance
Talimogene Laherparepvec
ATC code
L01XX51
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Imlygic 106 plaque forming units (PFU)/mL solution for injection / Imlygic 108 plaque forming units (PFU)/mL solution for injection
Marketing authorisation holder
Amgen Europe B.V.
Information as of
2026-10-28

Key facts

Talimogene laherparepvec (Imlygic) is an oncolytic herpes simplex virus type 1 injected directly into melanoma lesions, used for unresectable metastatic melanoma without visceral disease.

What it is used for

  • 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.

Dosing

  • Injected into cutaneous, subcutaneous and/or nodal lesions; up to a maximum of 4 mL in total per treatment visit.
  • Initial dose: up to 4 mL at 10⁶ (1 million) PFU/mL; second dose 3 weeks later and all subsequent doses every 2 weeks: up to 4 mL at 10⁸ (100 million) PFU/mL.
  • Volume per lesion depends on size, from up to 0.1 mL (≤ 0.5 cm) to up to 4 mL (> 5 cm); largest and new lesions are prioritised.
  • Continued for at least 6 months while injectable lesions remain, unless there is no benefit; may be reinitiated if new lesions appear after a complete response.

Contraindications

  • History of hypersensitivity to talimogene laherparepvec or any of its excipients.
  • Severely immunocompromised patients (e.g. severe congenital or acquired cellular and/or humoral immune deficiency).

Important warnings

  • Disseminated herpetic infection, including serious cases, has been reported; immunocompromised patients may be at increased risk.
  • Accidental exposure can transmit the virus; healthcare professionals and close contacts should avoid direct contact with injected lesions or body fluids during treatment and up to 30 days after the last treatment.
  • Immune-mediated events (glomerulonephritis, vasculitis, pneumonitis, worsening psoriasis, vitiligo) have been reported.
  • Plasmacytoma near the injection site and obstructive airway disorder have been reported; caution when injecting lesions close to major airways.
  • Efficacy data in second or later line settings are limited.

Side effects

  • Most common (≥ 25%): fatigue (50.3%), chills (48.6%), pyrexia (42.8%), nausea (35.6%), influenza-like illness (30.5%) and injection site pain (27.7%); 98% were mild or moderate.
  • Most common grade 3 or higher reaction: cellulitis (2.1%).
  • Common: herpes infections; uncommon: incision site infection.

Interactions

  • Acyclovir and other antiviral agents may interfere with effectiveness if given systemically or topically at the injection site.

Pregnancy and breastfeeding

  • As a precaution, use during pregnancy is preferably avoided; effective contraception during treatment, and a latex condom during sexual contact to prevent transmission.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ImlygicAmgen Europe B.V. · EMEA/H/C/002771

Source: European Medicines Agency (EMA), product information

Brand names in 2 more European countries
Iceland
Imlygic
Norway
Imlygic

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Imlygic – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/imlygic-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.