The FDA has approved the Biologics License Application for Amgen’s 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. Amgen intends to make Imlygic available to patients in the US within a week.

Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce the immunostimulatory protein granulocyte-macrophage colony-stimulating factor (GM-CSF). Imlygic causes cell lysis, 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.

“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, MD, executive vice president of Research and Development at Amgen in a statement.

Howard L. Kaufman, MD, 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, noted “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 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.

Amgen says it is committed to helping clinically appropriate patients access medicines and will provide assistance for Imlygic in the US in the following ways:

• Free medicines through The Safety Net Foundation are available to qualifying individuals with no or limited drug coverage.
• Co-pay coupon program for Imlygic through the Amgen FIRST STEP™ Program to help commercially insured patients meet their co-payment obligations; this program has no income requirement. Further information about eligibility requirements can be found at www.amgenfirststep.com.

Information about independent co-pay assistance foundations that give grants to qualifying patients who have difficulty paying out-of-pocket costs for medicines manufactured from across all of the industry.