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FDA advisory committees to review T-VEC for metastatic melanoma treatment
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The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee and its Oncologic Drugs Advisory Committee will jointly review the biologics license application for talimogene laherparepvec, which is in development for the treatment of patients with metastatic melanoma.
The review is scheduled for April 29.
Talimogene laherparepvec (Amgen), commonly referred to as T-VEC, is an investigational oncolytic immunotherapy designed to selectively replicate in tumors and initiate an immune response to metastasized cancer cells.
The FDA is reviewing the biologics license application for use of the agent in treatment of patients with injectable regionally or distantly metastatic melanoma.
“We look forward to discussing the efficacy and safety profile of talimogene laherparepvec with the advisory committees, and we are committed to working closely with the FDA during its review,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a press release.
The FDA review of the talimogene laherparepvec biologics license application has a Prescription Drug User Fee Act action date of Oct. 27.