FDA approves Amgen's Imlygic as first oncolytic viral therapy in USA

28 October 2015

The US Food and Drug Administration has approved the Biologics License Application for Imlygic (talimogene laherparepvec; T-VEC), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery.

The news comes hot on the heels of a European recommendation for approval of this novel therapy from US biotech giant Amgen (Nasdaq: AMGN; The Pharma Letter October 24). Amgen’s shares gained 2.1% to $161.98 by close of trading in New York yesterday.

Modest sales forecast

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