FDA approves Imlygic for the treatment of melanoma lesions

The US Food and Drug Administration (FDA) has approved Amgen’s Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.

Commenting on the approval, Karen Midthun, M.D., director of the FDA’s Centre for Biologics Evaluation and Research, said, “Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat. This approval provides patients and health care providers with a novel treatment for melanoma.”

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

Imlygic has a ‘unique approach’

“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, 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.”

Amgen intends to make Imlygic available to patients in the US within a week. Amgen 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, Amgen expects variability of Imlygic dosing from patient to patient. Therefore, the company said that it intends to work with the healthcare community to implement a programme that helps limit the average cost of Imlygic therapy to $65,000 for eligible participating institutions.