Talimogene laherparepvec regulatory update

FDA approved a BLA from Amgen for Imlygic talimogene laherparepvec for local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma that is recurrent after initial surgery. It is the first FDA approval of an oncolytic viral therapy. Imlygic is a modified herpes simplex virus type 1 (HSV-1) carrying the gene for GM-CSF.

Amgen launched Imlygic in the U.S. at a wholesale acquisition cost (WAC) of $4,400 for a 100 million PFU/mL single-use vial and $44 for a 1 million PFU/mL single-use vial. The company expects the average cost of the treatment to be about $65,000. Amgen also said it plans 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.” ...