Clinical Considerations for Oncolytic Viral Therapies: A Regulatory Perspective.

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. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.