DENDREON FILES PARTIAL BLA FOR PROSTATE CANCER IMMUNOTHERAPY

Dendreon has submitted the clinical and non-clinical sections of the rolling submission of a biologics license application (BLA) to the FDA 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 submission.

The clinical section of the application contains the evidence supporting the safety and efficacy of the drug 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.

The FDA has granted fast-track review status to the drug, enabling Dendreon to submit its application on a rolling basis so the FDA can review individual sections before receiving the complete submission. If approved, Provenge would be the first commercially available active immunotherapy, sometimes referred to as therapeutic cancer vaccine, to treat advanced hormone-refractory prostate cancer.