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FDA Approves T-VEC for Advanced Melanoma

Dr. Karen Midthun

Karen Midthun, MD

The FDA has approved the first-in-class oncolytic immunotherapy talimogene laherparepvec (T-VEC; Imlygic) for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery, based on results from the phase III OPTiM study.

In the pivotal trial, T-VEC significantly extended durable response rates (DRR) compared with GM-CSF. DRR was the primary endpoint, with overall survival (OS) as a secondary endpoint. In the final OS analysis, a 4.4-month extension with T-VEC was observed; however, this was not deemed to be statistically significant (P = .051).

Based on the OPTiM data, members of the FDA’s ODAC and CTGTAC panels voted 22-1 to recommend approval of T-VEC following a joint committee meeting in late April. Click here to read the full article at

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