Talimogene Laherparepvec for Treatment of Unresectable Cutaneous, Subcutaneous, and Nodal Melanoma Lesions

Source: ASCO Post, November 2015

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.

On October 27, 2015, talimogene laherparepvec (Imlygic) was approved for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. It is the first U.S. Food and Drug Administration–approved oncolytic virus therapy.

Supporting Efficacy Data

Approval was based on the finding of an improved durable response rate in an open-label phase III trial in which 436 patients with stage IIIB, IIIC, or IV melanoma considered to be unresectable were randomly assigned to receive talimogene laherparepvec (n = 295) or granulocyte-macrophage colony-stimulating factor (GM-CSF [Leukine]).^1,2