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Home » DENDREON'S PROVENGE BLA GRANTED PRIORITY REVIEW
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.
KEYWORDS Drug Pipeline Alert
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