Dendreon Announces Plans to Submit Application for FDA Approval of Provenge for the Treatment of Advanced Prostate Cancer

16-Sep-2005

Dendreon Corporation announced plans to submit a biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to market Provenge®, the Company's investigational immunotherapy for the treatment of advanced prostate cancer.

This decision follows a recent pre-BLA meeting in which the Company reviewed safety and efficacy data with the FDA from its two completed Phase 3 clinical trials of Provenge in patients with advanced prostate cancer. The outcome of these discussions determined that the survival benefit observed in the D9901 study in conjunction with the supportive data obtained from study D9902A and the absence of significant toxicity in both studies is sufficient to serve as the clinical basis of a BLA submission for Provenge.

As reported earlier this year, the final three-year follow up of the D9901 Phase 3 study of Provenge in 127 men with asymptomatic, metastatic, androgen-independent prostate cancer showed a median survival benefit of 21 percent or 4.5 months and a three-fold improvement in survival at 36 months (p-value = 0.01; hazard ratio = 1.7) for patients who were randomized to receive Provenge compared to placebo. This hazard ratio implies that patients who received placebo have a 70 percent greater relative risk of dying than patients who received Provenge.

Final three-year follow up of the D9902A Phase 3 study of Provenge in 98 men with asymptomatic, metastatic, androgen-independent prostate cancer showed a 20 percent improvement in median survival for patients who were randomized to receive Provenge compared to placebo. In addition, at the three-year final follow up, the percentage of patients alive in the Provenge-treated group was substantially greater than the percentage of patients alive who received placebo.

In both studies, as in previous studies, Provenge was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days.

https://www.bionity.com/en/news/48978/dendreon-announces-plans-to-submit-application-for-fda-approval-of-provenge-for-the-treatment-of-advanced-prostate-cancer.html