Amgen’s metastatic melanoma drug not suitable for accelerated approval, say FDA staff

USA-based Amgen’s (Nasdaq: AMGN) marketing application for talimogene laherparepvec (T-Vec) currently does not support it being reviewed under an accelerated approval pathway, according to briefing documents  prepared by agency staff released ahead of the US Food and Drug Administration’s advisory committee meeting tomorrow.

Documents for the Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee looked at the drug’s Biologics License Application (BLA), the primary evidence of effectiveness of talimogene laherparepvec comes from Study 005/05. In this randomized, Phase III study, subjects who received talimogene laherparepvec had a statistically significant higher durable response rate, including complete or partial response maintained for at least six months, compared with subjects who received control (GM-CSF) (15.6% versus 1.4%; p < 0.0001). Amgen has applied to have the investigational oncolytic immunotherapy cleared for the injectable treatment of regionally or distantly metastatic melanoma.

The document stated: “However, it was unclear whether talimogene laherparepvec administration was also associated with improvement in overall survival. With regard to safety, the most common treatment-emergent adverse events associated with talimogene laherparepvec were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection-site pain. Serious adverse events associated with talimogene laherparepvec included cellulitis, impaired wound healing, and immune-mediated disease (eg, glomerulonephritis). Shedding data were limited. The applicant has proposed a pharmacovigilance plan to collect post-marketing safety data.”