Dendreon Corp. received approval from the FDA for the expansion of its NJ manufacturing facility, allowing the company to significantly increase the availability of Provenge (sipuleucel-T), a treatment for metastatic castrate resistant (hormone refractory) prostate cancer.

The FDA approved Provenge last April. At that time Dendreon had 12 workstations at its NJ facility to supply the drug. The FDA has approved 36 additional workstations, bringing the total workstation count to 48. With the additional workstations, Dendreon expects to have approximately 225 infusion centers prepared to treat their first patient by the end of the 2Q11, approximately 450 infusion centers by 4Q11, and approximately 500 by the end of the year.

“The significant 4.1 month median survival benefit PROVENGE demonstrated represents a major milestone in the treatment of metastatic CRPC. To put Provenge in perspective, over the past 15 years, there have only been three other therapies in any metastatic cancer setting to show a survival benefit of four months or more,” said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. “With FDA approval of the additional NJ workstations, we now have significant capacity to make this important therapy available to the many men across the U.S. who may benefit from it.”