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Food and Drug Administration

Cellular, Tissue and Gene Therapies Advisory Committee Meeting

March 29, 2007

Sponsor: Dendreon Corporation

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

BLA STN 125197/0

Sipuleucel-T is an autologous active cellular immunotherapy indicated for the treatment of men with asymptomatic metastatic androgen independent prostate cancer (AIPC) (pdf)

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.

Clinical Briefing Document (pdf)

Errata - AC clinical briefing document (htm)

Statistical Briefing Document (pdf)

Errata - AC statistical briefing document (htm)

CMC Briefing Document (pdf)

Errata- Chemistry, Manufacturing and Controls Briefing Document (htm)

Addendum 1: Chemistry, Manufacturing and Controls Briefing Document (htm)

Bibliography (htm)


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