New melanoma drug Imlygic from Amgen gets approved by FDA but with label warning

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The US Food and Drug Administration (FDA) has given their sign of approval on Tuesday, Oct. 27, to Amgen's Imlygic (talimogene laherparepvec), a cancer immunotherapy against the dreaded melanoma lesions found in the skin and lymph nodes.

Imlygic, a genetically engineered herpes virus known to cause cold sores, replicates inside cancer cells when injected into the melanoma lesions. This will cause the tumors to burst open and, eventually, die. This type of drug is the first of its kind and can be really helpful for those cases where melanoma cannot be removed through surgery.

"The study showed that 16.3 percent of the study participants who received Imlygic experienced a decrease in size of their skin and lymph node lesions, lasting for a minimum of six months, compared to 2.1 percent of the study participants receiving the comparator therapy," the FDA said in a press release.

"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."

Some of the side effects that Imlygic may cause include fatigue, chills, fever, nausea, flu-like symptoms and pain at the injection site. The label of the new drug also warns about the possible transmission of herpetic infection upon accidental exposure. It also restricts the use of the product by pregnant women and those with compromised immune system

According to the FDA, skin cancer tops the list of the different types of cancer affecting people from the United States. And of the different types of skin cancer, melanoma, which is most often caused by exposure to ultraviolet (UV) light, has the highest risk of death among patients.

In 2015 alone, a total of 10,000 lives will be lost out of 74,000 Americans diagnosed with melanoma according to the estimate of the National Cancer Institute.

"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, M.D., director of the FDA's Center for Biologics Evaluation and Research. "This approval provides patients and health care providers with a novel treatment for melanoma."

According to Amgen, they have also been doing further studies to determine the efficacy of the drug when combined with immunotherapies in advanced melanoma and other solid tumor cancers. They estimate the average cost of Imlygic therapy to be around $65,000, and that it will be at the patients' disposal for no more than one week, Reuters wrote in an article.