Imlygic (talimogene laherparepvec) has been approved by the U.S. Food and Drug Administration to treat melanoma of the skin and lymph nodes.
Melanoma is the leading cause of death from skin cancer, affecting some 74,000 additional Americans annually and killing about 10,000, the FDA said in a news release.
Imlygic, made from a genetically modified herpes virus, is approved to treat melanoma that cannot be completely surgically removed. It’s injected directly into melanoma lesions, where it reproduces inside cancer cells and is designed to rupture and kill those cells, the agency said.
The drug is to be administered every two-to-three weeks for about six months, unless other treatment is needed or there are no additional lesions to treat, the FDA said.
Imlygic was evaluated in clinical studies involving more than 435 people with spreading melanoma that couldn’t be removed by surgery. Some 16 percent of participants given the drug had lesions on the skin and lymph nodes shrink, compared to about 2 percent of participants given a placebo.
However, the drug hasn’t been proven to extend survival or to have an effect on melanoma that has advanced to inner organs such as the brain, bone, liver or lungs, the agency said.
Imlygic’s most common side effects include fatigue, chills, fever, nausea, flu-like symptoms and injection-site pain. Since the product is derived from a modified herpes virus, it is possible to acquire herpes from the drug, which as a result shouldn’t be given to people who are pregnant or have weakened immune systems.
The drug is produced by a subsidiary of Thousand Oaks, Calif.-based Amgen Inc.
Learn more about this approval from the FDA.