FDA Approves Imlygic (Talimogene Laherparepvec) for Melanoma

The US Food and Drug Administration (FDA) has approved a first-of-its kind treatment for melanoma tumors in the skin and lymph nodes that can’t be removed completely by surgery.

Imlygic (talimogene laherparepvec) is an oncolytic virus therapy. It’s a genetically modified herpes virus that’s injected directly into the melanoma tumors. It is thought to work by multiplying inside the cancer cells and killing them, as well as by alerting the immune system to attack the cancer cells.

The FDA based its decision on a study of 436 people with melanoma that had spread and that couldn’t be removed through surgery. Of those who received Imlygic, 16.3% saw their lesions shrink for at least 6 months, compared to 2.1% for those who received a different therapy. The study did not show that Imlygic helped patients live longer, and it did not show that Imlygic had an effect on melanoma that had spread to the brain, bone, liver, lungs, or other internal organs.

Treatment with Imlygic involves a series of injections into the melanoma tumors. After the first injection, a second dose is given 3 weeks later, and then every 2 weeks, typically for at least 6 months. The most common side effects are fatigue, chills, fever, nausea, flu-like symptoms, and pain at the injection site. Because Imlygic is a modified live virus, herpes virus infection can also occur. Imlygic should not be given to people with suppressed immune systems or women who are pregnant.

Imlygic is marketed by BioVex Inc., a subsidiary of Amgen Inc.

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