Dendreon Completes Construction of New Jersey Manufacturing Facility
"The completion of the initial build-out of our New Jersey manufacturing facility is an important milestone on the path to our PROVENGE license application for marketing approval, which we plan to submit to the FDA later this year," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We are committed to bringing PROVENGE to the market to help the many men with late-stage prostate cancer and believe this achievement brings us one step closer to this goal."
PROVENGE is an investigational product that, according to the company, 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. ACIs hold promise because they may provide patients with a meaningful survival benefit with low toxicity. PROVENGE targets the prostate cancer antigen, prostatic acid phosphatase (PAP), which is found in approximately 95% of prostate cancers. PROVENGE is in clinical development for the treatment of patients with early-stage and advanced prostate cancer. In clinical studies, patients typically are randomized to receive three infusions of PROVENGE or placebo over a one-month period as a complete course of therapy.
Most read news
Other news from the department manufacturing
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.