New Therapy Method Used to Treat Melanoma Approved by FDA

New Therapy Method Used to Treat Melanoma Approved by FDA

November 4, 2015

The Food and Drug Administration (FDA) has approved a new treatment option for one of the most common forms of cancer.

The agency has issued an approval for Imlygic (talimogene laherparepvec), the first oncolytic virus therapy for the treatment of melanoma lesions in the skin and lymph nodes.

"Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat," Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a written statement. "This approval provides patients and health care providers with a novel treatment for melanoma."

Imlygic, a genetically modified live oncolytic herpes virus therapy, is used to treat melanoma lesions that cannot be removed completely by surgery. Imlygic is injected directly into the melanoma lesions, where it replicates inside cancer cells and causes the cells to rupture and die.

A treatment course with Imlygic consists of a series of injections into the melanoma lesions. After the initial injection, a second dose is administered three weeks later, followed by additional doses every two weeks for at least six months, unless other treatment is required or until there are no remaining injectable lesions to treat.

The most common side effects observed in clinical study participants were fatigue, chills, fever, nausea, flu-like symptoms and pain at the injection site.

Imlygic is manufactured by BioVex Inc., a subsidiary of Amgen Inc.

Skin cancer is the most common form of cancer in the United States, and melanoma, caused by exposure to ultraviolet light, is its most deadly form. According to the National Cancer Institute, approximately 74,000 Americans will be diagnosed with melanoma and nearly 10,000 will die from the disease in 2015.