FDA approves Amgen’s new biologic Imlygic

THOUSAND OAKS, Calif. — Amgen announced Wednesday that it had received approval from the Food and Drug Administration for Imlygic (talimogene laherparepvec) for injection. The drug is an oncolytic viral therapy indicated to treat melanoma patients with unresectable cutaneous, subcutaneous and nodal lesions that recur following initial surgery. 

 

The drug will be available within a week, according to Amgen, which estimated the cost of Imlygic therapy to cost $65,000. As a result of the cost, the company is working to provide assistance to patients through a co-pay coupon program and free medicines to qualifying patients through the Safety Net Foundation.

 

“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,” Amgen’s EVP of research and development, Dr. Sean Harper, said. “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.”