FDA to review Amgen drug for use on melanoma

Amgen said on Wednesday that its Biologics License Application (BLA) for talimogene laherparepvec will be reviewed by the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) and the Cellular, Tissue and Gene Therapies Advisory Committee.

Talimogene laherparepvec is an investigational oncolytic immunotherapy intended to selectively replicate in tumors and to begin an immune response to target cancer cells that have metastasized.

Currently, the FDA is reviewing the medication’s BLA as a treatment for patients with injectable regionally or distantly metastatic melanoma. The advisory committees will review talimogene laherparepvec at a meeting on April 29.

“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," Sean Harper, executive vice president of research and development at Amgen, said. "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."

Melanoma is the most aggressive form of skin cancer, and  approximately 132,000 cases occur each year. Melanoma makes up less than 5 percent of skin cancer cases in the U.S., but is the leading cause of skin cancer deaths.