|Amgen's first-in-class Oncolytic Drug wins FDA Approval|
|By Damian Garde-FierceBiotech|
|Wednesday, 28 October 2015 13:45|
The injection, called talimogene laherparepvec, is a so-called oncolytic immunotherapy, using a genetically modified strain of the herpes virus to invade tumors and replicate itself, thereby killing cancer and spurring an immune response to multiply its effect. Abbreviated T-Vec, the treatment is approved for inoperable melanoma that has already endured first-line therapy, and Amgen plans to launch it within a week under the brand name Imlygic.
In the Phase III trial supporting its approval, injecting T-Vec into melanoma lesions shrank tumors at a statistically significant rate, meeting the primary endpoint of the study, but Amgen's treatment fell narrowly short of hitting its secondary goal of extending overall survival. The mixed results haven't hampered Amgen's case to regulators, however, and Imlygic is in line for European approval by year's end.