) received a complete  response letter, commonly referred to as an “approvable” letter, on May 8,  2007, from the FDA regarding its biologics license application (BLA) for  Provenge (sipuleucel-T) for the treatment of asymptomatic, metastatic,  androgen-independent (also known as hormone refractory) prostate cancer.

The FDA has requested additional clinical data in support of the  efficacy claim contained in the BLA. The company is seeking a clarification  from the FDA as to the nature of the data that are being requested. The agency  has also requested additional information with respect to the chemistry,  manufacturing, and controls (CMC) section of the BLA, which the company  believes it can supply to the FDA in a timely manner.

On March 29, 2007, the FDA’s Office of Cellular, Tissue, and Gene  Therapies Advisory Committee was asked if the submitted data established  that Provenge is reasonably safe and whether there is substantial evidence that  the product is efficacious. The Advisory Committee voted 17 to 0 in favor of  the safety of the drug and 13 to 4 in favor of its efficacy. 

News

Dendreon Corporation (Seattle, WA, www.dendreon.com) received a complete response letter, commonly referred to as an "approvable" letter, on May 8, 2007, from the FDA regarding its biologics license application (BLA) for Provenge (sipuleucel-T) for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.