Seattle, Washington-based biotechnology company, Dendreon Corp. (DNDN) said Monday that it has submitted an amended Biologics License Application with the U.S. Food and Drug Administration for its investigational drug Provenge, indicated as a treatment for men with metastatic castrate-resistant prostate cancer, or CRPC.
Prostate cancer is the most common non-skin cancer in the United States, with more than 1 million men already diagnosed and estimated 192,280 new cases for 2009. Approximately 27,360 men are expected to die this year from the disease.
Traditional vaccines prevent disease, while Provenge treats it. If approved by the FDA, the drug would be the first approved cancer immunotherapy, or a drug to fight cancer by stimulating the immune system to attack cancer cells. Upon approval, the drug is estimated to fetch more than $1 billion in annual revenues within a few years.
In 2006, the company submitted a BLA and also requested a Priority Review for Provenge with the FDA. In March 2008, the FDA agreed to amend Dendreon's Special Protocol Assessment for phase 3 study of Provenge.
The amended BLA included data from IMPACT study, or IMmunotherapy for Prostate AdenoCarcinoma Treatment, that met its pre-specified primary endpoint of 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. We look forward to working with the FDA to potentially make PROVENGE the first active cellular immunotherapy to be licensed in the United States." noted Mitchell Gold, president and chief executive officer of Dendreon.
Dendreon has recently announced its plans for clinical trial of Neuvenge, its active cellular immunotherapy targeting the Her2-Neu pathway in bladder cancer, breast and colorectal cancers in late 2010 or early 2011.
DNDN is currently trading up 3.74% at $26.21, on the Nasdaq.
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