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Dendreon: Provenge on course to hit blockbuster goal

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In the first three months following the FDA's approval of the revolutionary new prostate cancer vaccine Provenge, Dendreon was able to gin a mere $2.8 million in sales as it began to ramp up production. But sales are rising at a fast pace and July saw more than $5 million in new Provenge revenue as the Seattle-based company picks up the pace as it heads towards its blockbuster goal of $1 billion a year.

Analysts have been following every step Dendreon takes as it gears up production of Provenge at three different manufacturing sites around the country. A New Jersey facility will be online in early 2011 with two other manufacturing centers in Atlanta and Orange County beginning production by the middle of next year. Analysts appeared pleased to see that 500 prescriptions of the therapy--a three-course treatment program costs $93,000--puts it on course to treat 2,000 patients in its first year.

Every hint of trouble, including a review of the drug by Medicare, has ruffled analysts and roiled Dendreon's stock price, which soared to $57 on the euphoria over Provenge's approval and then swiftly plunged. On Wednesday the stock jumped 17 percent as investors registered their approval of the biotech's quarterly report, rising to close to $40 a share.

Leerink Swann's Howard Liang was glad to hear that most Medicare contractors are already covering the therapy in advance of next year's review. "The current coverage is much broader than we expected based on our search of announced CMS coverage, which we already viewed positively," he noted.

Concern over the upcoming review spurred the American Society of Clinical Oncology, which represents 28,000 oncology specialists, to send the agency a letter outlining its worry that Medicare may be on the verge of setting an unsettling precedent. Medicare is required to cover drugs approved by the FDA, says ASCO, urging the agency to issue clear statements on its reimbursement policy.

- read the Reuters story
- here's the Wall Street Journal report

Related Articles:
NEJM lays out questions--and facts--about Provenge
Dendreon shares routed by Medicare Provenge review news
Provenge gets clean bill of health on safety, side effects


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Provenge is the new HIV (Human Immunodepleting Vaccine). Jokes aside, we MUST verify that it is not immunosuppressing cancer patients (like it did the placebo patients in the IMPACT trial). Dendreon’s self-imposed supply constraint (only 2000 patients in 12 months) makes it possible to run a prospective study of a fraction of these patients (let’s say 1000) while comparing them to prognosis-matched patients who are not receiving provenge (so there are no ethical issues of withholding an approved treatment). This would give us the proper controlled trial which we never had (unlike the IMPACT trial, where placebo patients were immunodepleted). However, Dendreon refuses to do this, although it would not interfere with manufacturing or reimbursement. At best for them, it would show that Provenge works better than imagined. Are they scared that with a proper comparator arm it will be obvious that this intervention shortens life?

Kind of confused about your comment. As the treatment involves isolation of dendritic cells by phoresis from the patient, I guess this is where you came up with the immunodepleting part of your joke. Think about it Katherine, when a cancer patient recieves chemotherapy what do you think this does to the immune system, not to mention the depletion of normal highly proliferating cells? Also, the dendritic cells are reinfused into the pateint after antigen loading and activation rendering them (the patient) more immunocompetent than before the treatment. My problem is the Dendreon touted very short "extended" life span of the prostate cancer patient after provenge treatment.

Bob, the immunodepletion theory is actually not a joke and a little more complicated: Dendreon does not advertised that the manufacturing process loses about half of the cells which are pheresed from patients (this came up only on the review documents that got posted on the FDA website after the approval). So, if they pherese out X number of cells, in the end the patient are reinfused with only about X/2 cells. Meanwhile, according to the study protocol, in the phase 3 trial, placebo patients were reinfused with only 1/3 of their original cells (on top of the manufacturing loss), while the Provenge patients were reinfused with their whole original load. Now, in older people, all of the naive t-cells which are needed for anti-tumor action are found only in the circulation. This is the cell population being depleted due to the pheresis and manufacturing loss, and it cannot be replenished from tissue lymphocyte stores or from the thymus (which in older people has involuted). So in the trial, old people were losing specifically naive t-cells and these were not being replenished (other kinds of t-cells were comming out from the tissues to replace them, so the total blood counts looked "fine" but the naive cells were gone). I agree that chemotherapy immunodepletes people as well, and that is a terrible thing, but chemotherapy also achieves anti-tumor effect (i.e. the tumor shrinks, chemo kills t-cells AND tumor cells), but the tumors don't shrink with Provenge. Remember that Provenge was never able to show any anti-tumor effects or effects on disease progression, so what then did the antigen loading achieve? However comparison to chemotherapy is beyond the point, because it's not what the trial tested and was not ground for FDA approval. Provenge was tested against placebo not directly against chemotherapy. And the issue is that it seems the Dendreon trial immunosuppressed the placebo patients *more* than the Provenge patients, and this created the 4-month survival difference which became ground for approval. That's what I mean by immunodepletion. This theory is all over the internet.

Control matters! That is a common sense in our life. IT looks like that the control in the provenge studies was problematic, thus creating the controversials we know today. Can we afford ignoring these controversials? Answer from your heart!
For the best interest of patients, does Obama administration have the ability to help solve the HIV-like problem? Money saved from this one may help eradicate the real HIV in the country.

Provenge has been approved by the FDA and No further testing is required.

FDA approval just means the benefits of the drug seem to outweigh the risks; it does not mean the drug is 100% safe or even 100% effective. Adverse event information will be collected and the approval decision can be reversed if future data tip the balance of benefit and risk.

Is FDA 100% mistake free? All the evidence we have now suggests that provenge has no antitumor activity nor a prolongation of survival. The difference is survival likely from the suppressed control. Ask you a simple question: are you rich? that depends on whome you want to compare to.

Body immune could not destroy or kill tumor cell. If it could patient should not develop cancer. Immune only react on foreign tissue just like transplantation.

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