Dendreon submits part of rolling Provenge BLA

US drugmaker Dendreon has submitted the clinical and non-clinical sections of the rolling submission of a Biologics License Application to the Food and Drug Administration for Provenge (sipuleucel-T) for the treatment of asymptomatic patients with metastatic, androgen-independent prostate cancer.

The company plans to submit the chemistry, manufacturing and controls section later this year, which will complete the BLA for approval to market the immunostimulating drug.

The clinical section of the BLA contains the evidence supporting the safety and efficacy of the agent for the treatment of men with advanced prostate cancer. In particular, this section of the BLA contains the clinical trial data supporting the conclusion that Provenge confers an advantage in overall survival, without significant toxicity, to men with asymptomatic, metastatic, androgen-independent prostate cancer.