FDA Approves Talimogene Laherparepvec for Recurrent Melanoma

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The FDA has approved talimogene laherparepvec (Imlygic) for the local treatment of  lesions in patients with melanoma.
The FDA has approved talimogene laherparepvec (Imlygic) for the local treatment of lesions in patients with melanoma.

The U.S. Food and Drug Administration (FDA) has approved talimogene laherparepvec (Imlygic), the first FDA-approved genetically modified oncolytic viral therapy, for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery, according to a press release by the FDA.1

“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, MD, 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.”

Treatment with talimogene laherparepvec consists of an initial injection, followed by a second dose administered 3 weeks later and then additional doses every 2 weeks for at least 6 months. Treatment is continued until other treatment is required or there are no remaining injectable lesions to treat.

The most common adverse events associated with talimogene laherparepvec treatment in clinical trials were fatigue, chills, pyrexia, nausea, flu-like symptoms, and pain at the inject site. The most common grade 3 or higher adverse event was cellulitis.

Health care providers should be aware that because talimogene laherparepvec is a modified live oncolytic herpes virus therapy and herpes virus infection can occur in patients. It is contraindicated in immunosuppressed patients or those who are pregnant.

Approval was based on a pivotal multicenter, open-label, phase 3 OPTiM trial that evaluated the safety and efficacy of talimogene laherparepvec in 436 patients with advanced melanoma that was not surgically resectable.

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Results showed that 16.3% of patients who received talimogene laherparepvec achieved a durable response compared with 2.1% of those treated with granulocyte-macrophage colony-stimulating factor (GM-CSF; P < .0001).2

“Advanced melanoma remains a complex disease to treat, requiring the use of several modalities over the course of a patient's therapeutic journey,” said Howard L. Kaufman, MD, the principal investigator for OPTiM, associate director for clinical science at the Rutgers Cancer Institute of New Jersey and president of the Society for Immunotherapy of Cancer. "As an oncolytic viral therapy, Imlygic has a unique approach, and provides another option for treating eligible patients with unresectable disease that has recurred after initial surgery.”


  1. FDA approves first-of-its-kind product for the treatment of melanoma [news release]. Bethesda, MD: U.S. Food and Drug Administration; October 27, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncPressA/ucm469571.htm. Accessed October 28, 2015.
  2. FDA approves Imlygic (talimogene laherparepvec) as first oncolytic viral therapy in the US [news release]. Thousand Oaks, CA: Amgen; October 27, 2015. https://www.amgen.com/media/news-releases/2015/10/fda-approves-imlygic-talimogene-laherparepvec-as-first-oncolytic-viral-therapy-in-the-us/. Accessed October 28, 2015.

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