New Drug Applications

Provenge

sipuleucel-T

Treatment for Prostate Cancer

D.C. Denies Prostate Cancer Vaccine, Provenge: Dendreon (WA) Not FDA To Blame

CHARLOTTESVILLE, Va., July 30, 2007 /PRNewswire/ -- Many in the prostate cancer community are still outraged over the FDA's decision to deny approval for the immunotherapy drug Provenge. Some have even gone as far as to make threats against Howard I. Scher of Memorial Sloan-Kettering Cancer Center (NY) and Maha Hussain of University of Michigan, two physicians who influenced this decision.

However, Dr. Charles "Snuffy" Myers, leading PC oncologist and VA prostate cancer survivor, remains staunch in his objections to the trials Dendreon presented to the FDA despite the benefits the drug might bring to his patients and himself. Myers has written extensively on this subject in his Prostate Forum newsletters 10 #01 and 10 #02, available at http://www.prostateforum.com.

"Dendreon made major and obvious mistakes in developing Provenge. The FDA is not some sort of bad guy -- at least in this case and yet Dendreon's stock continues to rise," Myers' says. "The primary end point of a clinical trial seeking FDA approval should be either survival or improved quality of life, but Dendreon still chose to muddy the waters by changing endpoints midway through the clinical trial, forcing the FDA's hand with their poor design."

"This is actually the second time that we've had a useful drug fail in development. The other was Atrasentan (a.k.a. Xinlay)," Myers adds. "Again, it failed not because of the FDA but because of drug company incompetence. While the FDA is far from perfect, people need to understand who to blame in this case."

"I can understand the anger," Myers says, "but is it really unreasonable to ask for proof that a drug is safe and either improves survival or quality of life? I think that Provenge is an active agent with a definite, but limited, benefit, so I feel a personal loss now that it is not going to be available. But killing the messenger doesn't change the message; it just obscures the real problem -- and solving problems is what modern medicine should really be about."

Former director of the UVA Cancer Center, Dr. Charles "Snuffy" Myers is the author of the acclaimed Beating Prostate Cancer: Hormonal Therapy & Diet and runs the American Institute for Diseases of the Prostate to treat patients with the same tools that saved his own life. For more information or to read Dr. Myers' opinions on Provenge visit http://www.prostateforum.com.

CONTACT: Rod Schecter of Prostate Forum, +1-347-405-4118

Web site: http://www.prostateforum.com/

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company

Related Articles:

Prostate Cancer Patients, Survivors and Advocates Assemble on Capitol Hill to Rally against FDA's Non Approval of Provenge - June 1, 2007

Dendreon Announces FDA Confirms Data Required for Provenge Licensure - May 31, 2007

Dendreon Receives Complete Response Letter From FDA for Provenge Biologics License Application - May 9, 2007

Dendreon Announces FDA Advisory Committee Reviewed Provenge for Hormone Refractory Prostate Cancer - March 30, 2007

Dendreon to Hold Post Advisory Committee Conference Call for Provenge - March 27, 2007

Dendreon Announces FDA's Cellular, Tissue and Gene Therapies Advisory Committee to Review Provenge for the Treatment of Asymptomatic, Metastatic, Androgen-Independent Prostate Cancer - March 1, 2007

Dendreon’s Provenge Granted FDA Priority Review - January 16, 2007

Dendreon Completes Submission of Biologics License Application to FDA for Provenge in Hormone Refractory Prostate Cancer - November 13, 2006