SEATTLE, March 10, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN) announced today that the U.S. Food and Drug Administration (FDA) approved the remainder of its New Jersey manufacturing facility, allowing the company to significantly increase the availability of PROVENGE® (sipuleucel-T) to help meet the needs of patients with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
Last April, upon receiving FDA approval of PROVENGE, Dendreon launched the world's first patient-specific prostate cancer immunotherapy from 12 workstations in its New Jersey facility. With the FDA approval of 36 additional workstations, the New Jersey facility will now have a total of 48 approved workstations. Dendreon will bring these new workstations online in a staged approach.
PROVENGE is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers, and is the first in a new therapeutic class of drugs known as autologous cellular immunotherapies.
"PROVENGE has the largest reported survival benefit in patients with asymptomatic or minimally symptomatic metastatic prostate cancer, with the most common side effects being primarily transient and mild to moderate. As such, PROVENGE is the standard of care for these patients," said Daniel George, M.D., director of GU Medical Oncology and the Prostate Clinic at Duke University Medical Center. "The increased availability of PROVENGE will allow more treatment centers and patients across the country to access this important treatment option."
In anticipation of the availability of the additional workstations, Dendreon expects to have approximately 225 infusion centers prepared to treat their first patient by the end of the second quarter, approximately 450 infusion centers upon en