The FDA Approves Oncolytic Virus Therapy for Melanoma Skin Cancer

The United States Food and Drug Administration (FDA) approved an oncolytic virus vaccine for use in the treatment of malignant melanoma skin cancer for the first time. The vaccine named Lmlygic (talimogene laherparepvec) was approved for treating melanoma lesions occurring in the skin and lymph nodes.

Melanoma, an aggressive type of skin cancer, is a serious cancer that progresses and frequently spreads to other parts of the body, which can make treatment challenging. Approval of this therapy provides patients and physicians with a new treatment option for melanoma.

Although relatively rare, melanoma incidence has risen over the past 30 years more than 2-fold in our country and worldwide. It is outside our country's top 10 cancers in both sexes, but in America ranks 5. in men and 7. in women.

Lmlygic, a genetically modified live oncolytic herpes (cold sore) virus therapy, is used to treat melanoma lesions that cannot be completely removed surgically. Imlygic, injected directly into the melanoma lesion, multiplies inside the cancer cell and causes the cell to break apart and die.

A course of Lmlygic treatment consists of a series of injections directly into the melanoma lesion. After the first injection, the second dose is administered 3 weeks later. Additional doses are then given for at least 6 weeks, once every 2 weeks. This continues if no other treatment is desired, or until the lesions are eliminated by treatment.

The effectiveness and safety of Lmlygic were evaluated in 436 patients with advanced (metastatic) melanoma that could not be treated surgically. Approximately % 16 of participants receiving Lmlygic had shrinkage of lesions in both the skin and lymph nodes that lasted at least 6 months. By contrast, lesion shrinkage was identified in %2 of control patients. However, this study did not show that Lmlygic improved overall survival or benefited melanoma that had spread to the brain, bones, liver, lungs or other internal organs.

We previously discussed cancer vaccines including Lmlygic in detail; to read that article, click here.