Dendreon Corporation has completed the submission of the amended Biologics License Application (BLA) for Provenge (sipuleucel-T), the company's lead investigational product, to the US Food and Drug Administration (FDA). Dendreon is seeking licensure for Provenge for men with metastatic castrate-resistant prostate cancer (CRPC). If approved by the FDA, Provenge would represent the first product in the new therapeutic class known as active cellular immunotherapies.

The amended BLA includes data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with the FDA. The IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC.

"With the BLA submission complete, we have taken an important step towards reaching our goal of bringing a new therapy to men with advanced prostate cancer," said Mitchell H Gold, MD, president and chief executive officer of Dendreon. "We look forward to working with the FDA to potentially make Provenge the first active cellular immunotherapy to be licensed in the United States."

Provenge is available through several ongoing clinical trials, including OpenACT, an open label trial enrolling men with metastatic CRPC, ProACT (PROstate cancer Active Cellular immunoTherapy), and NeoACT (NEOadjuvant Active Cellular immunotherapy).

Provenge is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies (ACIs) specifically designed to engage the patient's own immune system against cancer.

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics.