FDA Issues Complete Response Letter for Sipuleucel-T Biologics License Application

Dendreon Corporation recently announced that it received a Complete Response Letter, commonly referred to as an "approvable" letter, on May 8, 2007 from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for sipuleucel-T (Provenge) for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer.

The FDA has requested additional clinical data in support of the efficacy claim contained in the BLA, as well as additional information with respect to the chemistry, manufacturing and controls section of the document.

"We are committed to working closely with the FDA to resolve these questions in a timely and efficient manner to bring Provenge to patients with advanced prostate cancer who currently have few appealing treatment options," said Mitchell H. Gold, md, president and chief executive officer of Dendreon.

Dendreon's BLA was submitted under a Fast Track designation and was accepted for filing by the FDA in January 2007. The BLA was based primarily on a multicenter, randomized, double-blind, placebo-controlled phase III study (D9901) that showed that the group of men with asymptomatic, metastatic, androgen-independent prostate cancer who received sipuleucel-T had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo. Men who received sipuleucel-T had a 41% overall reduction in the risk of death (P = .010; hazard ratio = 1.7). In addition, 34% of patients receiving sipuleucel-T were alive 36 months after treatment, compared to 11% of patients randomized to receive placebo.

Ongoing Clinical Study

IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) also known as D9902B, is an ongoing phase III clinical trial measuring overall survival in men with hormone-refractory prostate cancer receiving sipuleucel-T vs those receiving placebo.

In order to be eligible to participate in the IMPACT study, a person must have cancer that has spread outside the prostate or that has worsened while on hormone therapy among other additional criteria. Interested patients should contact the Dendreon Prostate Cancer Information line at 1-866-4PROSTATE (1-866-477-6782).