Dendreon

From Wikipedia, the free encyclopedia

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. The FDA 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.[1]

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."[2]

In 2006, the company built a manufacturing facility in Hanover, New Jersey to accomodate 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)[3].

In January 2007, the FDA accepted Dendreon's Biologics License Application filing for Provenge, with an FDA decision due by May 15, 2007. [4]

In March 2007, the FDA's Office of Cellular, Tissue and Gene Therapies Advisory Committee voted 17-0 in favor of the safety of Provenge and 13-4 in favor of the efficacy of Provenge. 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. [5]

Provenge (sipuleucel-T) consists of autologous dendritic cells complexed with the PAP antigen and GM-CSF.

  1. ^ "US panel: Dendreon cancer therapy appears to work", Reuters via Yahoo! News, Mar 29, 2007.
  2. ^ Dr.Scott Gottlieb. "Prostate Drug Promise Vs. FDA Rigidity", Forbes, February 18, 2005.
  3. ^ Luke Timmerman. "Building factory a balancing act for Dendreon", Seattle Times, August 9, 2006.
  4. ^ Adam Feuerstein (March 16, 2007). Dendreon's Date with Destiny. thestreet.com.
  5. ^ Dendreon Investor Relations (March 29, 2007). Dendreon Announces FDA Advisory Committee Reviewed Provenge for Hormone Refractory Prostate Cancer. dendreon.com.

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