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
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