Results from a Phase 1 study of NEUVENGE, Dendreon’s candidate vaccine for breast cancer, appeared today in Journal of Clinical Oncology. Testing of Neuvenge in clinical trials runs several years behind Provenge, which is in an ongoing Phase 3 trial. Out of 18 patients with advanced breast cancer who received Neuvenge, 1 patient showed partial response for 6 months and 3 patients had stable disease lasting more than a year.
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A link to a 5 hour video recording of the FDA Advisory Committee hearing held March 29 on sipuleucel-T (Provenge) for advanced, androgen independent prostate cancer. The video does not include the vote.

A full written transcript in .pdf including the voting is online at FDA, click here.

Oncologist Dr. Howard I. Scher has received a death threat for opposing immediate FDA approval of Dendreon’s Provenge therapeutic vaccine for prostate cancer. Another oncologist who opposes approval of Provenge without completion of an ongoing clinical trial, Dr. Maha Hussain, has received unspecified threats.
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Data presented today from an ongoing study designed to explore the biologic and clinical activity of cancer immunotherapy sipuleucel-T, or Provenge, in patients with early stage recurrent prostate cancer who have a rising serum prostate specific antigen (PSA) level, but who have not yet developed metastatic disease are not all that impressive. The study showed that sipuleucel-T did not significantly delay the time it took for a patient’s PSA to reach a value of 3 ng/ml, the primary endpoint of the study, but it did show a prolongation in prostate-specific antigen doubling time (PSADT). An “early trend” toward slowing the time to metastatic disease for patients who received sipuleucel-T compared with those who received placebo “did not reach statistical significance.”

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Dendreon announced today that the FDA will accept “either a positive interim or final analysis of survival” from its ongoing Phase III randomized clinical trial of Provenge immunotherapy for androgen independent prostate cancer.

In a press release, the company said it “has received confirmation that the U.S. Food and Drug Administration (FDA) will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to supplement the Biologics License Application (BLA) for PROVENGE (sipuleucel-T). This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.”
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Jim Kiefert, chair of the executive committee of US Too International prostate cancer support group, interviewed yesterday at the American Urological Association (AUA)’s annual meeting by CNBC’s pharmaceuticals reporter Mike Huckman, said some members of his support group wept when they heard FDA had delayed approval of Dendreon’s vaccine for advanced prostate cancer, Provenge. The interview with Kiefert is part of the video at this CNBC link. Meanwhile advocates are signing a petition and plan to demonstrate in Washington D.C. and hope to meet with the head of the FDA.
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Seattle P-I reporter DAN RICHMAN in an article updated tonight writes:

Seattle-based Dendreon Corp. will delay releasing its much-anticipated Provenge drug to fight prostate cancer until at least next year and possibly until 2010, spokeswomen said Thursday.

Because of that delay, the company Thursday cut 15 percent of its 250-person work force, laying off the roughly 40 staffers who were preparing to begin marketing Provenge later this year, said one spokeswoman, Monique Greer, in an interview Thursday morning.

The Food and Drug Administration last week unexpectedly declined to approve Provenge, Dendreon’s only product, without more data supporting the drug’s effectiveness.

“We expect interim data in 2008, but it’s event-driven, by deaths or survival, so it could be 2010 until we have final-survival analysis,” Greer said in an interview Thursday morning. The drug will make it to the market “at the earliest in 2009, potentially,” she said.

She said the company plans to meet with the FDA in the near future and will base its next steps on the results of that meeting.

Full Story Seattled PI, Dendreon will Delay Provenge…

A site to advocate for “Provenge Now!” has been launched. Provenge is Dendreon’s immunotherapy for prostate cancer, which was approved 17-0 for safety and 13-4 for efficacy by an FDA Advisory Committee vote March 29th this year. On May 9, Dendreon announced that FDA has sent them a “Complete Response Letter,” commonly called an approvable letter, requesting more data. Dendreon CEO Mitchell Gold said “The FDA has requested additional clinical data in support of the efficacy claim.”
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In today’s Wall Street Journal, Mark Thornton, M.D., Ph.D. deplores the FDA’s decision on Dendreon’s sipuleucal-T immunotherapy (Provenge vaccine). Dr. Thornton says “May 9, 2007, should be cited in the annals of cancer immunotherapy as Black Wednesday. Within an eight-hour period that day, the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient’s immune system against cancer. The FDA’s hubris will affect the lives and possibly the life spans of cancer patients from nearly every demographic, from elderly men with prostate cancer to young children with the rarest of bone cancers.”
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Dendreon’s CEO Mitchell Gold traded some of his stock during the high period following the FDA Advisory panel vote on his company’s prostate cancer immunotherapy sipuleucal-T (Provenge). Gold told the WSJ Health blog that he sold “less than 20%” of his holdings in the company following the upbeat FDA advisory panel vote. “It’s all public,” he said, without elaborating.

More of a surprise is to see that Steve Fleischmann, one the patients who spoke passionately to the FDA committee, did the same:

Before the stock tanked some savvy investors cashed in. One of them was businessman Steve Fleischmann, who became a prostate cancer patient, activist and Dendreon shareholder all in the same year. “I bought Dendreon in 2003; I’ve owned it for years,” he told the Health Blog. But he shed some of his shares after Dendreon surged at the end of March on a panel of experts’ recommendation that FDA approve the vaccine. He declined to quantify his holdings or profits, but said, “I wanted to take some of my chips off the table so I wasn’t so invested. It’s natural.”

Still, Fleischmann decried the protracted tug of war among investors in the company: “The sad thing is that Dendreon became more of a stock play than a humanistic play – a game between longs and shorts – and all about padding people’s pockets.”

Wall Street Journal Health Blog

Raise a Voice, an advocacy group for advanced prostate cancer patients, which is calling for patient access to drugs that have passed through Phase I trials, has written a thank you letter to the FDA Advisory Committee on Dendreon’s sipuleucel-T (Provenge). The letter is signed by 19 prostate cancer advocacy groups including US Too International and National Prostate Cancer Coalition.
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Dr. Thomas R. Fleming, Ph.D., a prostate cancer survivor and nationally recognized statistician specializing in clinical trials design and analysis, has written a letter urging FDA officials not to approve Dendreon’s application at this time.

Echoing concerns about post-hoc analysis expressed by FDA statistical reviewer Dr. Bo-Guang Zhen, Fleming disagrees with a prostate cancer survivor on the FDA’s March 29 advisory committee who said that Dendreon’s sipuleucel-T (Provenge) vaccine offers "an opportunity to make a choice."

Fleming writes: "As a fellow person living with prostate cancer I strongly disagree with [this] statement that all patients want is a ‘choice.’ Patients want an ‘informed choice.’”

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When Provenge vaccine for prostate cancer is approved by the FDA, as most likely it will be on or by May 15, this decision to make this new therapy available immediately to any patient who can afford or whose insurance covers it — rather than to delay approval until the results are in from a larger clinical trial — will be due to Michael Milken. In Cora Daniels’ blockbuster article for Fortune Magazine (November 2004), The Man Who Changed Medicine, reprinted at Cptech.com, Milken said:

I believe the person who waits for 110% of the facts to be in and all the information is a person who is probably not alive — because it’s too late for him. A lot of businesspeople have been forced to make decisions without 100% or perfect information but based on what they know. I worked in a field where ten seconds was a long decision process. Either you’re buying the securities or you’re not. Either you’re selling them or you’re not. Now people said, ‘Well, gosh, that’s a short period of time,’ and I say, ‘No, it’s not.’ I’ve prepared my entire life to make that decision. I think getting off that inertia of making a decision qualifies well in building something.

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Dr. Maha Hussain (left) is calling for an open access program for Dendreon’s Provenge prostate cancer vaccine (Sipuleucel-T) pending completion of an ongoing, 500 man clinical trial, She made this suggestion March 29 during the FDA Advisory Committee hearing after voting “No” on the vaccine’s efficacy. She followed up with a letter to the FDA reiterating her “No” position and again calling for an open access program.

Dr. Hussain is the second oncologist among 4 members of the panel who voted “No” to the efficacy of the drug who has followed up with a letter to the FDA.
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Dr. Maha Hussain, an oncologist who was one of 4 out of 17 members of the FDA Advisory Committee to vote against accepting against the company’s claim to efficacy for Provenge (Sipuleucel-T) prostate cancer vaccine, is calling for an expanded access program to empower patients who want and need it to receive the drug while an ongoing 500 man clinical trial of Provenge is completed.
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This is the text of Howard Scher M.D.’s letter to FDA about the March 29th advisory committee hearing on Dendreon’s vaccine Sipuleucel-T (Provenge):

I am writing to express concerns about the recent review of Sipuleucel-T at the FDA Advisory Meeting on March 29, 2007. These concerns are: a recommendation for approval based on data that fall short of the regulatory requirements; an inadequate statistical construct to determine definitive benefit; incomplete data on product safety; and what appear to be different criteria for approval by two Advisory Committees to the Agency.

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