title: Clinical Considerations for Oncolytic Viral Therapies: A Regulatory Perspective.
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.
authors.affiliation: Oncology Branch, Division of Clinical Evaluation, Pharmacology and Toxicology, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
authors.forename: K
authors.initials: K
authors.lastname: Liu
mesh_terms: D017277:Drug Approval; D006801:Humans; D007883:Legislation, Medical / Q000639:trends*; D008545:Melanoma / Q000628:therapy; D050130:Oncolytic Virotherapy / Q000009:adverse effects / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration