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The FDA just approved the first of a revolutionary set of new drugs.
Imlygic, a cancer drug developed by biotech company Amgen, uses a genetically modified herpes virus that’s programmed to kill tumor cells in patients with melanoma that recurs after surgery.
Melanoma is the most dangerous form of skin cancer, characterized by unusual moles or pigment areas. The cancerous cells form in the cells responsible for the color of your skin.
The new drug will cost $65,000 for a course of treatment. That’s much less than other new cancer treatments, which typically cost more than $100,000, with some new treatments costing more than $250,000 in the first full year of treatment. Amgen said in a news release that it expects the drug to become available starting next week.
A new kind of treatment
Imlygic is the first FDA-approved oncolytic viral therapy, and it’s just the beginning for this kind of treatment.
Oncolytic virus development has been in the works for more than 20 years, and the concept of using viruses to fight disease has been around for more than 100 years. The basis of the drug is a modified herpes virus. That means it won’t infect the person with herpes, but instead attack the cancerous cells directly, and may stimulate an immune system response to tumors especially in combination with other chemotherapy drugs. It will be used to treat lesions, or the areas of skin that still have moles and other marks related to melanoma, if they pop up again after being surgically removed.
To put it simply, the mutated virus will be injected directly into the cancerous mole.
According to the FDA, 16.3% of participants in a clinical study saw a decrease in their lesions that lasted for at least 6 months. That was better than the results of the comparative therapy it was tested against.
An estimated 74,000 people are diagnosed with melanoma in the United States per year, and it’s responsible for 1.7% of all cancer deaths in the US.
Like all drugs, Imlygic does come with some caveats. So far, the drug has not been proven to increase overall survival. It also hasn’t been shown to be effective against melanoma that’s spread to other organs in the body. IT’s got some side effects, too: The FDA disclosed that the most common ones were fatigue, fever, nausea, flu-like symptoms and pain – and maybe herpes, since the drug is a modified herpes virus.
Imlygic won’t have too much of an effect on Amgen’s profits. Forbes reports that analysts expect the drug will bring in about $200 million in sales per year, so it won’t be like a typical blockbuster drug that makes billions.