Dendreon Corporation of Seattle has presented to the FDA the clinical and non-clinical sections of its rolling submission of a Biologics License Application (BLA) for Provenge (sipuleucel-T).
The product is a therapeutic vaccine for asymptomatic, metastatic, hormone-refractory prostate cancer. It is designed to stimulate a patient’s own immune system to recognize and destroy prostate cancer cells. In a recent Phase III study, 34% of patients receiving a complete course of Provenge were alive 36 months later compared with 11% of placebo recipients.
Dendreon plans to complete the submission of the BLA to gain marketing approval for the product later this year.