(RxWiki News) There's a new, first-of-its kind treatment for the deadliest type of skin cancer.
“Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “This approval provides patients and health care providers with a novel treatment for melanoma.”
Here's how it works: Imlygic is injected directly into melanoma lesions that cannot be removed completely by surgery. The drug is actually a genetically modified, live, oncolytic herpes virus. Patients will receive a series of injections. Once injected, this BioVex, Inc., drug replicates itself inside the cancer cells, causing the cells to burst and die.
The FDA did note that Imlygic does pose a risk of herpes virus infection. That's why the agency said patients who have compromised immune systems or who are pregnant should not receive this treatment. Other side effects included flu-like symptoms, fatigue, fever, chills and nausea, among others.
The FDA approved Imlygic after the drug appeared safe and effective in a study of 436 patients with advanced melanoma. Just over 16 percent of the patients who received Imlygic saw their melanoma lesions decrease in size.
"However, Imlygic has not been shown to improve overall survival or to have an effect on melanoma that has spread to the brain, bone, liver, lungs, or other internal organs," according to an FDA press release.
BioVex, Inc., is a subsidiary of Amgen, Inc.