Talimogene laherparepvec

Drug Profile

Talimogene laherparepvec

Alternative Names: Herpes simplex virus type 1 GM CSF vaccine; IMLYGIC; JS1/34.5- /47-/GM-CSF; JS1/34.5- /47-/GM-CSF vaccine; OncoVEXGM-CSF; T-VEC

Latest Information Update: 06 Dec 2016

Price : $50

At a glance

  • Originator BioVex
  • Developer Amgen; BioVex; M. D. Anderson Cancer Center; Merck & Co; University of Iowa
  • Class Gene therapies; Oncolytic viruses
  • Mechanism of Action Apoprotein stimulants; Apoptosis stimulants; Granulocyte colony stimulating factor stimulants
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Malignant melanoma
  • Phase II Breast cancer
  • Phase I/II Soft tissue sarcoma
  • Phase I Head and neck cancer; Liver cancer
  • No development reported Pancreatic cancer; Solid tumours

Most Recent Events

  • 07 Oct 2016 Interim efficacy and adverse events data from phase II part of the phase I/II trial in Malignant melanoma (Combination therapy, First-line therapy, Inoperable/Unresectable) presented at the 41st Congress of the European Society for Medical Oncology (ESMO-2016)
  • 01 Aug 2016 Phase-II clinical trials in Breast cancer (Monotherapy, Inoperable/Unresectable, Locally recurrent, Second-line therapy or greater) in USA (Intratumoural) (NCT02658812)
  • 27 Apr 2016 Amgen plans a phase I trial for non-central nervous system Solid tumours (Late-stage disease, Second-line therapy or greater, In neonates, In infants, In children, In adolescents) in USA (Intralesional, Injection) (NCT02756845)
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