FDA committee: Hormone-refractory PCa agent shows 'substantial evidence' of efficacy, safety

The FDA’s Office of Cellular, Tissue and Gene Therapies Advisory Committee has recommended to the FDA that there is substantial evidence of efficacy and safety of sipuleucel-T (Provenge) for patients with asymptomatic, metastatic hormone-refractory prostate cancer. If the FDA concurs with the committee’s report, sipuleucel-T would be the first active cellular immunotherapy and the first biologic approved to treat prostate cancer.

Dendreon Corp., manufacturer of sipuleucel-T, anticipates a decision by mid-May.