Tuesday, November 3, 2015

First viral therapy for melanoma approved

CANCER DIGEST – Nov. 3, 2015 – The U.S. Food and Drug Administration has approved Imlygic (talimogene laherparepvec), the first FDA-approved anti-cancer virus therapy, for the treatment of melanoma in the skin and lymph nodes.

Imlygic is a genetically modified live herpes virus engineered to kill cancer cells. It is used to treat melanoma tumors that cannot be removed completely by surgery. Imlygic is injected directly into the melanoma lesions, where it replicates inside cancer cells and causes the cells to rupture and die. 
A treatment course with Imlygic consists of a series of injections into the melanoma lesions. After the initial injection, a second dose is administered three weeks later, followed by additional doses every two weeks for at least six months, unless other treatment is required or until there are no remaining injectable lesions to treat.

The safety and efficacy of Imlygic were evaluated in a multicenter study of 436 participants with melanoma that had spread to other tissues in the body beyond the skin, and could not be surgically removed. The participants’ melanoma lesions in the skin and lymph nodes were treated with Imlygic or a comparison therapy for at least six months, or until there were no remaining injectable lesions. 

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 comparison therapy. 

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.  

The most common side effects observed in clinical study participants were fatigue, chills, fever, nausea, flu-like symptoms and pain at the injection site.

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