Amgen has announced that the U.S. Food and Drug Administration (FDA) has approved the 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 has not been shown to improve overall survival or have an effect on visceral metastases. Imlygic 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. However, the exact mechanism of action is unknown.
Metastatic melanoma continues to be one of the most difficult-to-treat cancers because it is often 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 health of the patient.4,5 Despite new therapeutic options, additional treatments are needed – particularly for patients with metastatic disease.
Amgen intends to make Imlygic available to patients in the U.S. 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, Amgen 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.