The FDA has approved Amgen’s Biologics License Application for IMLYGIC (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery.

IMLYGIC, which has not been shown to improve overall survival or have an effect on visceral metastases, is the first oncolytic viral therapy approved by the FDA based on therapeutic benefit demonstrated in a pivotal study.

IMLYGIC is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce an immunostimulatory protein called granulocyte-macrophage colony-stimulating factor (GM-CSF). IMLYGIC causes cell lysis, or death, which ruptures tumors, releasing tumor-derived antigens which, along with GM-CSF, may promote an anti-tumor immune response. The exact mechanism of action, however, is unknown.

“IMLYGIC is the first clinical and regulatory validation of an oncolytic virus as a therapy, which Amgen is proud to bring to patients with a serious form of skin cancer. Not all melanoma patients currently benefit from available therapies, and IMLYGIC represents an important new option that can provide meaningful durable responses for patients with this aggressive and complex disease,” said Sean Harper, M.D., executive vice president of research and development at Amgen. “Immunotherapy is an exciting area for cancer research, and we are currently studying IMLYGIC in combination with other immunotherapies in advanced melanoma and other solid tumors.”

“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 Kaufman, M.D., 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.”

Metastatic melanoma continues to be one of the most difficult-to-treat cancers because it often is insensitive to chemotherapy, can be highly aggressive, and can require several different types of treatment depending on the stage and location of the disease and the health of the patient. Despite new therapeutic options, additional treatments are needed—particularly for patients with metastatic disease.

Thousand Oaks, Calif.-based Amgen intends to make IMLYGIC available to patients in the U.S. by next week. It anticipates the average cost of IMLYGIC therapy to be approximately $65,000. Given that IMLYGIC represents a novel and first-in-class oncolytic viral therapy, the company expects variability of IMLYGIC dosing from patient to patient. Amgen therefore intends to work with the healthcare community to implement a program that helps limit the average cost of IMLYGIC therapy to $65,000 for eligible participating institutions.