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Dendreon is a Seattle based biotechnology company. Its leading product candidate, Sipuleucel-T (known as Provenge during drug trials), is an immunotherapy for prostate cancer. Provenge (sipuleucel-T) consists of autologous (reimplanted) dendritic cells complexed with the PAP antigen and GM-CSF.
Additional recommended knowledge
Path to FDA approval
In his February 18, 2005 column in Forbes magazine, Dr. Scott Gottlieb, who later served as a top policy maker with the FDA until early 2007, argued for Provenge approval: "That 4.5-month increase in survival is almost double the 2.5-month benefit shown in clinical trials of Taxotere, a drug that is the next best thing for patients like those in the Provenge trial whose cancer has spread beyond the prostate gland and is no longer being controlled by hormonal therapy."
In 2006, the company built a manufacturing facility in Hanover, New Jersey to accommodate Provenge production in anticipation of possible FDA approval in 2007, as well as for production for a Phase III trial, IMPACT (previously known as D9902B).
In January 2007, the FDA accepted Dendreon's Biologics License Application filing for Provenge, with an FDA decision due by May 15, 2007.
The Food and Drug Administration (FDA) Office of Cellular, Tissue and Gene Therapies Advisory Committee on March 29 2007 voted 17-0 that Provenge is reasonably safe and 13-4 that the trial data showed substantial evidence that it is effective. The FDA has a set a PDUFA date of May 15, 2007 as its deadline to decide whether or not to grant approval to Provenge. The FDA is not bound to accept the recommendation of the advisory committee.
On May 9, 2007 DNDN dropped to just over $7 per share when the company received a letter from the FDA demanding more results and information before approval. The Seattle Times reported that layoffs are likely and quoted an industry analyst as saying that Dendreon will probably lay off half of its current workforce of 250.
On December 13, 2007 three US congressmen, Mike Michaud (D-Maine), Dan Burton (R-Indiana) and Tim Ryan (D-Ohio), requested a probe into the FDA's delay in approving Provenge and conflicts of interest held by certain advisory committee members.
|This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Dendreon". A list of authors is available in Wikipedia.|