FDA to Review Treatment Injected into Metastatic Melanoma Tumors

The gist: A treatment for metastatic melanoma called talimogene laherparepvec (T-VEC) will soon be reviewed by the FDA for treating patients with metastatic melanoma. If T-VEC is approved, doctors in the U.S. will be free to prescribe it to their patients. T-VEC is an immune system-boosting treatment that is injected directly into melanoma tumors. Learn more about it in this Need to Know blog post.

“Amgen (NASDAQ: AMGN) announced today that the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) will jointly review the Company’s Biologics License Application (BLA) for talimogene laherparepvec. The FDA is currently reviewing the talimogene laherparepvec BLA for the treatment of patients with injectable regionally or distantly metastatic melanoma. The advisory committees will review talimogene laherparepvec at a meeting on April 29, 2015.

” ‘The incidence of melanoma has continued to rise in recent years, and even with recent additional options in treatment, there is an important unmet medical need,’ said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. ‘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 of the BLA.’ “