Matthew Herper, a writer for Forbes magazine and Forbes.com, has a biased, one-directional view of Dendreon’s Provenge, the first and only FDA-approved immunotherapeutic treatment for men with late stage prostate cancer. He continues to trip over his own feet in his attempts to lower the boom on Dendreon and Provenge. Over the past several years he even has attacked Care To Live, a prostate cancer patient advocacy group.

Mr. Herper could care less about the 30,000 men dying each year from an excruciatingly painful disease. He could care less about hurting a company financially that is attempting to cure not just prostate cancer, but many other forms of cancers as well. And he could care less about uncovering the malfeasance at the FDA Continue Reading Race To Undo The Cure »

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Although the Court of Appeals decision did not go our way in the case of CTL vs. FDA, whereby we are seeking documents Richard Pazdur declared he shredded and deleted, the Court was kind enough to inform us that our initial request was not specific enough. Therefore Care To Live has filed a new Freedom of Information Act (FOIA) request, which is on its way to the FDA’s Division of Freedom of Information as I post this.

CTL is asking for all documents and e-mails, among other things, sent to and from Richard Pazdur during the period October 1, 2006 through October 1, 2007, inclusive. CTL is quite specific this time in detailing exactly what we are asking them to search for.

The new FOIA request can be seen here:

ctl-cder-foia-request.pdf

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Dendreon announced updated results today from its pivotal Phase 3 IMPACT trial for late stage prostate cancer. The results were even better than we expected. According to Dendreon, the study “demonstrated that PROVENGE increased three-year survival by 40 percent compared to placebo.”

This is truly awesome and in line with what we always believed about the potential of Provenge and Immunotherapy. Dr. Phillip Kantoff, the Director of the Lank Center for Genitourinary Oncology, Chief of the Division of Solid Tumor Oncology, and Chief Clinical Research Officer at Dana-Farber Cancer Institute, Professor of Medicine at Harvard Medical School, and principal investigator of the IMPACT study, said it best:

“The results from the IMPACT study corroborate earlier studies with sipuleucel-T in demonstrating an improvement in overall survival for men with metastatic castration resistant prostate cancer.”

This is why CareToLive, represented by our attorney, Kerry M. Donahue, fought so long and so hard to keep Provenge in the limelight after the FDA delayed approval for almost 3 years to date.

The earlier studies which were reviewed by an FDA Advisory Committee back in March 2007 demonstrated survival, the FDA gold standard for approval of cancer treatments, especially for terminal patients who had no other options, yet we are still awaiting approval.

Dr. Kantoff reminded us that we are seeing medical history:

“This is the first therapeutic vaccine to demonstrate a survival benefit in cancer.”

This goes way beyond prostate cancer because Dendreon is going to use similar treatments to try to tackle other cancers, such as breast,  colon , ovarian cancer, etc.

Although safety was never a concern in prior trials, rumors abounded, and today, Dr. Kantoff, in the press release, tames that concern while reiterating the medical history we are about to experience:

“Furthermore, the results of this study validate cancer immunotherapy as an entirely new treatment paradigm that can provide patients with a clinically meaningful survival benefit coupled with a well-tolerated safety profile.”

CareToLive is thrilled to proudly broadcast this great news.

The three-year survival by 40% compared to placebo is record breaking. Now we need the FDA to  enable the men in dire need to get Provenge ASAP!

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