Amgen Announces FDA Advisory Committees To Review Talimogene Laherparepvec For The Treatment Of Patients With Metastatic Melanoma
THOUSAND OAKS, Calif., Feb. 11, 2015 /PRNewswire/ -- 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.
About the Cellular, Tissue and Gene Therapies Advisory Committee
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.
About the Oncologic Drugs Advisory Committee
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.
About Talimogene Laherparepvec
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (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 U.S., 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 U.S. has been increasing for the last 30 years.3
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 tumor site.4
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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National Cancer Institute, National Institute of Health, U.S. Dept. of Health and Human Services. What You Need to Know About Melanoma and Other Skin Cancers. June 2010. http://www.cancer.gov/publications/patient-education/skin.pdf.
Accessed Feb. 10, 2015.
World Health Organization. Ultraviolet radiation and the INTERSUN Programme. http://www.who.int/uv/faq/skincancer/en/index1.htmlAccessed Feb. 10, 2015.
Melanoma skin cancer overview. American Cancer Society website. http://www.cancer.org/acs/groups/cid/documents/webcontent/003063-pdf.pdf Accessed Feb. 10, 2015.
American Cancer Society. Melanoma Skin Cancer. http://www.cancer.org/acs/groups/cid/documents/webcontent/003120-pdf.pdf Accessed Feb. 10, 2015.
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