Drug Profile

Talimogene laherparepvec - Amgen

Alternative Names: AMG-678; IMLYGIC; JS1/34.5- /47-/GM-CSF; OncoVEX; OncoVEX^GM-CSF; T-VEC

Latest Information Update: 28 Aug 2025

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At a glance

Originator BioVex
Developer Amgen; BioVex; H. Lee Moffitt Cancer Center and Research Institute; M. D. Anderson Cancer Center; Merck & Co; Merck Sharp & Dohme Corp.; Roche; UNC Lineberger Comprehensive Cancer Center; University of California; University of Iowa
Class Antineoplastics; Gene therapies; Granulocyte-macrophage colony-stimulating factors; Immunotherapies; Oncolytic viruses
Mechanism of Action Cell death stimulants; Immunologic cytotoxicity; Immunostimulants

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Marketed Malignant melanoma
Phase II Basal cell cancer; Breast cancer; Soft tissue sarcoma
Phase I/II Liver cancer; Malignant pleural effusion; Triple negative breast cancer
No development reported Colorectal cancer; Head and neck cancer; HER2 negative breast cancer; Pancreatic cancer; Solid tumours

28 Aug 2025 No recent reports of development identified for phase-I development in Malignant-melanoma(Inoperable/Unresectable, Late-stage disease) in Japan (Intratumoural, Injection)
28 Aug 2025 No recent reports of development identified for phase-I development in Solid-tumours(In adolescents, In children, Late-stage disease, In adults) in Belgium (Intralesional, Injection)
28 Aug 2025 No recent reports of development identified for phase-I development in Solid-tumours(In adolescents, In children, Late-stage disease, In adults) in Canada (Intralesional, Injection)

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