News

Imlygic® Approved for Melanoma

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Imlygic (talimogene laherparepvec), the first ever FDA-approved oncolytic virus therapy, has been approved for the treatment of melanoma.

The approval is for the treatment of melanoma sites in the skin and lymph nodes that cannot be surgically removed. Imlygic is given as an injection directly into the site of cancer, and is given through a series of injections over the course of 6 months.

Melanoma is a type of skin cancer that typically starts in the form of a mole. If caught and treated early with surgical removal, cure rates remain high. However, if melanoma spreads outside its site of origin, especially if it has spread to other sites in the body, it can become deadly.

Melanoma has been difficult to treat in the past, as it did not respond well to standard chemotherapy and/or radiation therapy. However, researchers have recently developed newer agents which create improved anti-cancer responses and overall outcomes for patients with this disease.

Imlygic is a genetically modified live oncolytic herpes virus therapy. In essence, Imlygic consists of a herpes virus that has been genetically modified through laboratory processes.

Imlygic is injected into the site of the cancer, at which time the modified herpes virus replicates inside cancer cells, causing the cancer cells to rupture and die.

The trial leading to the approval of Imlygic included 436 patients with melanoma that had spread to distant sites in the body and could not be surgically removed. Patients received with Imlygic or a comparator therapy for at least 6 months, unless there were no visible melanoma sites left. Results from the different treatments were directly compared.

  • 16.3% of patients treated with Imlygic experienced a decrease in the size of their melanoma sites in the skin and lymph nodes for at least 6 months, compared to only 2,1% of patients treated with the comparator therapy.
  • Imlygic has not yet demonstrated an improvement in survival, or effectiveness of melanoma sites in the brain, bone, liver, lungs or other internal organs.
  • The most common side effects were flu-like symptoms and pain at the injection site.

Reference: United States Food and Drug Administration. News Release. FDA approves first-of-its-kind product for the treatment of melanoma. Available at:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm469571.htm. Accessed October 27, 2015.