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Talimogene laherparepvec - Amgen

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Drug Profile

Talimogene laherparepvec - Amgen

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

Latest Information Update: 05 Apr 2024

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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

Highest Development Phases

  • 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
  • Phase I Solid tumours
  • No development reported Colorectal cancer; Head and neck cancer; HER2 negative breast cancer; Pancreatic cancer

Most Recent Events

  • 26 Feb 2024 Amgen completes the phase II MASTERKEY-115 trial in Malignant melanoma (Combination therapy, Inoperable/Unresectable, Late stage disease, Metastatic disease, Second-line therapy or greater) in US, Australia, Canada, France, Germany, Greece, Italy, Netherlands, Poland, Spain, United Kingdom (Intralesional) (NCT04068181)
  • 02 Jun 2023 Efficacy and safety data from a phase II trial in Malignant melanoma presented at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO-2023)
  • 10 May 2023 Amgen along with Medical University Vienna completes a phase II Neo-BCC trial in Basal cell cancer (Late-stage disease, Neoadjuvant therapy) in Austria (Intralesional) (EudraCT2018-002165-19)
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