Amgen announced that the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) of the US 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," says Sean E. Harper, MD, 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.
The CTGTAC is a committee utilized by the FDA that reviews and evaluates data relating to the safety, effectiveness and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which 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 and makes recommendations to the FDA.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumours (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. The rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.
Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing the pigment to skin.1 Melanoma is the most aggressive and serious form of skin cancer. Currently, 132,000 melanoma cases occur globally each year.2 In the US, while melanoma accounts for less than five percent of skin cancer cases, it causes the most skin cancer deaths.3 The number of new cases of melanoma in the US has been increasing for the last 30 years.
Melanoma is considered to be advanced when it has spread, or metastasized, from the origin site to deeper parts of the skin or other organs, such as the lymph nodes, lungs or other parts of the body distant from the primary tumour site.