Latest Cancer News
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.
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.
-- Scott Roberts
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