Clinical Considerations for Oncolytic Viral Therapies: A Regulatory Perspective

Clin Pharmacol Ther. 2017 May;101(5):580-582. doi: 10.1002/cpt.640. Epub 2017 Apr 12.

Abstract

The US Food and Drug Administration (FDA) approved the first oncolytic viral therapy (OVT), Imlygic (talimogene laherparepvec), in October 2015 for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery, although talimogene has not been shown to improve overall survival or have an effect on visceral metastases.

Publication types

  • Review

MeSH terms

  • Drug Approval
  • Humans
  • Legislation, Medical / trends*
  • Melanoma / therapy
  • Oncolytic Virotherapy / adverse effects
  • Oncolytic Virotherapy / methods*
  • United States
  • United States Food and Drug Administration