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FDA Advisory Committees to Review Talimogene Laherparepvec for Metastatic Melanoma
The Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) of the FDA will jointly review the biologics license application (BLA) for talimogene laherparepvec (Amgen). The FDA is currently reviewing the drug’s BLA for the treatment of patients with injectable regionally or distantly metastatic melanoma.
The advisory committees’ joint review will take place on April 29, 2015. The Prescription Drug User Fee Act (PDUFA) action date for completion of the FDA review of the talimogene laherparepvec BLA is October 27.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not in normal tissues) and to initiate an immune response to target cancer cells that have metastasized. The drug was designed to work in two complementary ways. First, it is injected directly into tumors, where it replicates inside the tumor’s cells, causing the cells to rupture and die (lysis). The rupture of the cancer cells releases tumor-derived antigens, along with GM-CSF, which can stimulate a system-wide immune response in which white blood cells are able to seek out and target cancer that has spread throughout the body.
The CTGTAC reviews and evaluates data related to the safety, effectiveness, and appropriate use of human cells, human tissues, gene-transfer therapies, and xenotransplantation products that are intended for transplantation, implantation, infusion, and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair, or replacement of tissues for various conditions.
The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer.
Both committees make approval recommendations to the FDA.
Melanoma is characterized by the uncontrolled growth of melanocytes, the cells responsible for providing the pigment to skin. Melanoma is the most aggressive and serious form of skin cancer. An estimated 132,000 melanoma cases occur globally each year. Although melanoma accounts for less than 5% of skin cancer cases in the U.S., it causes the most skin cancer deaths. The number of new cases of melanoma in the U.S. has been increasing for the last 30 years.
Source: Amgen; February 12, 2015.