FDA Approves IMLYGIC™ (Talimogene Laherparepvec) As First Oncolytic Viral Therapy In The US

THOUSAND OAKS, Calif., Oct. 27, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for IMLYGIC™ (talimogene laherparepvec), 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. IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is the first oncolytic viral therapy approved by the FDA based on therapeutic benefit demonstrated in a pivotal study.1-3



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