Prostate Cancer Therapy

U.S. FDA agrees to special protocol assessment amendment to D9902B IMPACT study of Provenge

Published in Medical Letter on the CDC and FDA, January 1st, 2006

Dendreon Corp. (DNDN) announced that it has reached an agreement with the U.S. Food & Drug Administration (FDA) under the special protocol assessment (SPA) procedure to amend the design of its ongoing phase III (D9902B) clinical trial of PROVENGE (sipuleucel-T), the company's investigational active cellular immunotherapy for the treatment of advanced prostate cancer.

The SPA letter provides a written agreement between Dendreon and the FDA concerning the trial design and outlines definitive clinical objectives and data analyses.

The D9902B clinical trial was initiated in June 2003 under an SPA for the treatment of men with asymptomatic, metastatic,...

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Source: Medical Letter on the CDC and FDA (2006-01-01)

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