FDA Approves New Therapy for Prostate Cancer
April 29, 2010 — In a widely anticipated announcement, the US Food and Drug Administration (FDA) has approved an immunotherapy, sipuleucel-T (Provenge, Dendreon), for the treatment of asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer (mCRPC).
Often referred to as a vaccine, sipuleucel-T is an autologous active cellular immunotherapy, meaning that it is made from the patient’s own white blood cells and stimulates a patient’s immune system to respond against the cancer. The treatment needs to be manufactured individually for each patient.
“The availability of [sipuleucel-T] provides a new treatment option for men with advanced prostate cancer who currently have limited effective therapies available,” said Karen Midthun, MD, acting director of the FDA’s Center for Biologics Evaluation and Research, in a press statement.
Sipuleucel-T becomes the first product approved by the FDA in a new therapeutic class known as active cellular immunotherapies, according to Dendreon press materials.
