FDA advisory committees to review talimogene laherparepvec for metastatic melanoma treatment

Amgen announced that the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee will jointly review the company’s biologics license application for talimogene laherparepvec for the treatment of patients with metastatic melanoma.

The committees will review talimogene laherparepvec, an investigational oncolytic immunotherapy designed to selectively replicate in tumors and initiate an immune response to metastasized cancer cells, on April 29.

The FDA is currently reviewing the biologics license application (BLA) for treating patients with injectable regionally or distantly metastatic melanoma, according to an Amgen press release.

“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 BLA,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release.

The FDA review of the talimogene laherparepvec BLA has a Prescription Drug User Fee Act action date of Oct. 27, according to the release.

Reference: www.amgen.com.