DENDREON'S PROVENGE BLA GRANTED PRIORITY REVIEW

Dendreon announced that the FDA has assigned priority review status to the company's biologics license application (BLA) for Provenge (sipuleucel-T), its investigational active cellular immunotherapy for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer.

Priority review is granted to products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease, according to the company.

Clinical trials have shown that Provenge increases survival and is generally well tolerated in men with late-stage prostate cancer. The BLA submission is based primarily on an improvement in overall survival observed in Study D9901, a multicenter, randomized, double-blind, placebo-controlled Phase III study.

Provenge may represent the first in a new class of active cellular immunotherapies that are uniquely designed to stimulate a patient's own immune system, according to the company.