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www.fdanews.com/articles/90657-committee-to-review-dendreon-s-prostate-cancer-drug

COMMITTEE TO REVIEW DENDREON'S PROSTATE CANCER DRUG

March 5, 2007

Dendreon announced that the FDA's Cellular, Tissue and Gene Therapies Advisory Committee will review the company's biologics license application (BLA) for Provenge (sipuleucel-T), an investigational active cellular immunotherapy for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer March 29.

The company's application is based primarily on an improvement in overall survival observed in Study D9901, a multicenter, randomized, double-blind, placebo-controlled Phase III study. The results from D9901 were published in the July issue of the Journal of Clinical Oncology.

Dendreon completed the submission of its BLA for Provenge in November 2006, and the FDA granted priority review status to the application in January. The company anticipates a decision by the FDA within approximately six months after the submission date, or by May 15.