FDA approves first-of-its-kind melanoma treatment

Imlygic (talimogene laherparepvec) has become the first FDA-approved oncolytic virus therapy indicated 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. “This approval provides patients and health care providers with a novel treatment for melanoma.”

Skin cancer is the most common form of cancer in the United States. Melanoma, a particularly aggressive form, is the leading cause of skin cancer-related deaths.

Imlygic is a genetically modified live oncolytic herpes virus therapy used when lesions are not able to be completely removed surgically. It is administred via injection; after the first injection a second follows in three weeks, followed by injections every two weeks for a minimum of six months or until other treatment is necessary or no lesions are left.

Imlygic is a modified live oncolytic herpes virus therapy; therefore herpes virus infection is a risk.