FDA approves first-of-its-kind product for treating skin cancer

November 6, 2015

FDA has approved talimogene laherparepvec (Imlygic, Amgen) for the treatment of unresectable melanoma lesions.

FDA has approved the first oncolytic virus therapy: Talimogene laherparepvec (Imlygic, Amgen) for the treatment of unresectable melanoma lesions.

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Imlygic is indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. Imlygic is a genetically modified herpes simplex virus type 1 that is designed to replicate within tumors and produce an immunostimulatory protein, called granulocyte-macrophage colony stimulating factor (GM-CSF). The drug’s exact mechanism of action is unknown, but is thought to cause cell lysis and rupture of tumors, releasing tumor-derived antigens. These antigens, along with GM-CSF, may promote an anti-tumor immune response.

Melanoma, a type of skin cancer, is the leading cause of skin cancer related deaths and is most often caused by exposure to ultraviolet light. Metastatic melanoma is often insensitive to chemotherapy and can require several different types of treatment. According to the National Cancer Institute, approximately 74,000 Americans will be diagnosed and nearly 10,000 will die from melanoma in 2015.

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"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 the pivotal trial (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."

The safety and efficacy of Imlygic were demonstrated in the OPTiM study, a multicenter study of 436 patients with unresectable metastatic melanoma. The patients’ lesions were treated with Imlygic or a comparable therapy for at least six months, or until there were no remaining injectable lesions. Results showed that 16.3% of participants who received Imlygic experienced a decrease in size of their lesions, lasting for a minimum of six months, compared to 2.1% of participants receiving the comparator 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.

Fatigue, chills, fever, nausea, flu-like symptoms, and pain at the injection site were the most common side effects associated with the use of the drug in the study. Herpes virus infection may also occur, therefore Imlygic should not be given to individuals with compromised immune systems or to pregnant women.

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