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FDA Approves First-in-Class Oncolytic Virus Immunotherapy for the Treatment of Melanoma

Today marks a major advancement in the fight against skin cancer, as the U.S. Food and Drug Administration (FDA) approved a new immune-based therapy for treating metastatic melanoma. Amgen’s IMLYGIC (talimogene laherparepvec) commonly referred to as T-VEC, is among a new class of agents known as oncolytic virus immunotherapies. An oncolytic virus is a virus that preferentially infects and kills cancer cells. IMLYGIC is the first therapy in this class to receive FDA approval to treat melanoma.

IMLYGIC is a version of the herpes simplex virus that has been genetically modified to attenuate the virus, increase selectivity for cancer cells, and secrete cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF is a protein that is naturally secreted in the body that can promote an immune response. The virus invades both cancerous and healthy cells, but is unable to replicate in healthy cells, leaving them unharmed. Inside a cancer cell, the virus is able to replicate, secreting GM-CSF in the process. Eventually overwhelmed, the cancer cell ruptures, which destroys the cell and releases new viruses, GM-CSF, and an array of tumor-specific antigens.

“IMLYGIC offers a two-pronged approach for the treatment of metastatic melanoma. The combination of the virus with GM-CSF increases the drug’s cancer-killing effect while activating the immune system to kill melanoma cells—even those that are distant from the treated tumor,” said Lisa H. Butterfield, PhD, Professor of Medicine at the University of Pittsburgh and Vice President of the Society for Immunotherapy of Cancer (SITC). “IMLYGIC also offers simple administration; it can be injected in an office visit and importantly, has no serious side effects.”

Prior to its approval by the FDA, IMLYGIC was extensively studied in clinical trials that indicated the treatment improved durable response rates in patients with advanced melanoma. Durable response rate is defined as partial or complete response to treatment lasting continuously for at least six months.

Howard L. Kaufman, MD, FACS, Associate Director for Clinical Science at the Rutgers Cancer Institute of New Jersey and president of SITC, was the global principal investigator on the IMLYGIC studies, which were conducted in four countries with several SITC members as co-investigators.

Steve Silverstein, stage IV melanoma survivor and chair of the Melanoma Research Foundation’s board of directors, views IMLYGIC as an important new option for patients. “When I was diagnosed with stage IV melanoma a decade ago, I was stunned by the limited number of treatment options to fight my cancer,” said Silverstein. “I tried surgery, chemotherapies and chemo embolization—with no luck. My only chance at survival was an innovative immunotherapy (IL-2). I know firsthand just how important new treatment options are to the melanoma community, and the approval of IMLYGIC means another great tool in the toolbox for people with advanced melanoma. I am eager to see people fighting melanoma find another chance to beat this disease.”

According to Dr. Butterfield, the Society is thrilled that yet another immunotherapy agent has received FDA approval and will soon be providing benefit to patients. “SITC has been an important forum that supports the development of ground-breaking cancer treatments through dissemination and discussion of new findings, education and fellowships,” said Dr. Butterfield. “First presented at the 2011 SITC Annual Meeting, IMLYGIC is a perfect example of what it takes to develop successful immunotherapies for the future. By presenting the most innovative research and fostering collaboration, SITC has contributed to the increasing success of immunotherapy agents demonstrating clinical benefit.”

About the Society for Immunotherapy of Cancer

Established in 1984, the Society for Immunotherapy of Cancer (SITC) is a not-for-profit organization of medical professionals dedicated to improving patient outcomes by advancing the development, science and application of cancer immunotherapy. As the world’s leading member-driven organization dedicated to cancer immunotherapy and tumor immunology, SITC is comprised of nearly 1,000 influential basic and translational scientists, clinicians, health care professionals, government leaders and industry professionals from around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC aims to one day make the word “cure” a reality for cancer patients everywhere. For more information about SITC, please visit

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