Dendreon Corp. received approval from the FDA for Provenge (sipuleucel-T), an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). Provenge is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers.

“The FDA approval of Provenge is a testament to the courage of the patients and researchers who participated in our studies and is the culmination of nearly 15 years of R&D by our dedicated employees,” said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. “The approval of Provenge is a significant step towards realizing our mission of transforming the lives of patients with cancer, and it also marks Dendreon’s transformation into a commercial enterprise, ready to support the successful launch of the first personalized treatment for cancer.”

The company plans to make the drug available through approximately 50 centers, and expects to increase capacity over the next year. The increased capacity is pending the anticipated licensure of its expanded NJ, GA, and CA facilities in mid-2011.