Dendreon Corporation (Nasdaq: DNDN)’s Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) has been accepted and assigned priority review status by the USFDA.
PROVENGE® (sipuleucel-T) is Dendreon Corp.’s investigational active cellular immunotherapy for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer.
A product under USFDA priority review status will be granted decision six months from filing and is assigned 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 Mitchell H. Gold, president and chief executive officer of Dendreon:
"Clinical trials have shown that PROVENGE increases survival and is generally well tolerated in men with late-stage prostate cancer, a highly prevalent disease for which there are currently few available treatment options.
We are extremely pleased the FDA has granted priority review to PROVENGE, which may represent an important new treatment option for men suffering from prostate cancer."
Under late stage clinical development for the treatment of advanced prostate cancer, PROVENGE® (sipuleucel-T) is an investigational product that may represent the first in a new class of active cellular immunotherapies (ACIs) that are uniquely designed to stimulate a patient's own immune system.
Source: Dendreon Corp.
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