Dendreon Corporation has announced that the FDA approved its
Los Angeles cancer immunotherapy manufacturing facility, allowing the company
to continue to increase the availability of PROVENGE® (sipuleucel-T) across the
U.S. to help meet the needs of patients with asymptomatic or minimally
symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
The Los Angeles
facility includes 36 workstations, and Dendreon will bring these new workstations
online in a staged approach. With this FDA approval and the fully approved New Jersey facility,
Dendreon now has total of 84 workstations available to manufacture PROVENGE.
Dendreon expects to continue to provide additional capacity through the anticipated
licensure mid-year of one other manufacturing facility in the United States.
In April, Dendreon filed a post-approval supplement for its third
facility in Atlanta,
for which there is an FDA action date of August 28, 2011.
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.
“As the foundation of care, PROVENGE is an important
treatment option for men with metastatic castrate resistant prostate
cancer,” said Mitchell H. Gold, M.D., president and chief executive
officer of Dendreon. “The FDA approval of the Los Angeles facility will enhance our ability
to provide PROVENGE to the many patients across the country who may benefit
In anticipation of the availability of the additional
workstations, Dendreon expects to have approximately 225 active infusing sites
by the end of the second quarter and approximately 500 by the end of 2011.