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The FDA recently approved the remainder of Dendreon Corp.?s manufacturing facility, which will add 36 workstations for the manufacture of sipuleucel-T (Provenge), the company?s advanced prostate cancer immunotherapy.
The FDA recently approved the remainder of Dendreon Corp.’s manufacturing facility, which will add 36 workstations for the manufacture of sipuleucel-T (Provenge), the company’s advanced prostate cancer immunotherapy.
The approval increases the number of workstations to 48, according to a Dendreon press release. The company plans to bring these workstations online in a staged approach. In anticipation of the availability of these workstations, Dendreon said it expects to have approximately 225 infusion centers prepared to treat patients by the end of the second quarter and approximately 500 by the end of 2011.
"The increased availability of Provenge will allow more treatment centers and patients across the country to access this important treatment option," said Daniel George, MD, of Duke University Medical Center, Durham, NC.
Dendreon also filed a post-approval supplement on Feb. 28 requesting licensure of 36 workstations at its Los Angeles facility to manufacture the drug, and plans to file a post-approval supplement for its Atlanta facility as well.