Amgen (NASDAQ: AMGN) announced today that the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) will jointly review the Company's Biologics License Application (BLA) for talimogene laherparepvec. The FDA is currently reviewing the talimogene laherparepvec BLA for the treatment of patients with injectable regionally or distantly metastatic melanoma. The advisory committees will review talimogene laherparepvec at a meeting on April 29, 2015.
“The incidence of melanoma has continued to rise in recent years, and even with recent additional options in treatment, there is an important unmet medical need,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We look forward to discussing the efficacy and safety profile of talimogene laherparepvec with the advisory committees, and we are committed to working closely with the FDA during its review of the BLA.”
The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the talimogene laherparepvec BLA is Oct. 27, 2015.