Dendreon Corp. has received great news from the FDA about their pending application for the approval of Provenge.
STILL TIME TO SIGN PATIENT PETITION TO FDA FOR PROSTATE CANCER TREATMENT APPROVAL and Provengenow news– Click Here
NEW YORK (Dow Jones)–Dendreon Corp. (DNDN) Thursday said the Food and Drug Administration would accept interim trial data to meet the regulator’s request for additional information on the prostate cancer drug Provenge, sending the company’s shares sharply higher.
The surge in the Seattle company’s stock price reflects investors’ optimism that the cancer treatment – for which some project worldwide sales of more than $1 billion – may reach the market before final data is expected to be released in 2010.
“The FDA indicated that either a positive interim or final analysis of survival…would address their request for the submission of additional clinical data in support of our efficacy claim,” Chief Executive Mitchell H. Gold said in a press release. He added that the company expects to finish enrollment in the IMPACT study this year and sees interim survival results next year.
Shares of Dendreon were recently up $2.83, or 42%, at $9.57, with more than double the average daily volume of shares traded. Shares traded as much as 93% higher earlier Thursday.
Provenge is the first so-called active cellular immunotherapy drug, which tries to fight cancer by harnessing the body’s immune system. Current treatments attack the cancer cells directly.
Earlier this month, the FDA requested more clinical to support the effectiveness of the drug, which sent Dendreon shares plunging 60%. That followed an FDA panel recommendation in March after which the company’s stock price more than doubled.
At the time of the March meeting, nearly 33% of Dendreon’s float was sold short, as many doubted the treatment’s chances for approval. That number has since risen to 51% based on the latest figures available, which are through May 15, according to FactSet Research.
Assuming that the interim trial data holds up and does show that Provenge provides a statistically significant increase in survival rate, Provenge could be approved without the completion of the full pending trial. This would cut a full two years off the time we would have to wait to have Provenge available!
I believe that this flexibility on the part of the FDA is directly related to the pressure that has been placed on the agency. Patient advocates and physicians have joined in unprecedented numbers to urge that the FDA to reconsider its most recent decision delaying Provengeâ€™s approval. Malecare has gathered over 3,500 signatures on an Action letter to the FDA and there are currently plans for a rally in Washington and Chicago. Never before has the prostate cancer community gathered, with one voice, to insist that the number of drugs and treatments available for prostate cancer is increased.
It is my personal belief that the FDA has compromised as much as they can. I think it is now incumbent on our community to turn to Dendreon, and in one strong voice, insist that they reverse their prior decision not to support a Compassionate Use Program. PROVENGE NOW should mean NOW, with a Compassionate Use Program.
Joel T Nowak, MA, MSW
Let’s remember and stay focused on a few important things. First, the news today is NOT a compromise from the FDA. It is, in fact, them being hardline. The SPA under which 9902b is being conducted ALREADY provided for an interim analysis that would lead to licensure. What the company (and patients alike) had hoped for WAS a compromise from the FDA allowing either a free (no alpha spend) peek at the interim data OR use of TTP-look for approval, something that would indicate compromise.
Saying, “we’ll live up to the contract we already signed” is NOT a compromise and viewing it as such is foolish and diminishes the opportunity to rally support against the unbelievable injustice this has been and continues to be. DO NOT BE FOOLED. THE FDA HAS NOT COMPROMISED. THEY HAVE NOT GIVEN IN TO PATIENT PRESSURE. THEY HAVE NOT RECOGNIZED THE NEED FOR PROVENGE NOW. At least NOT YET!
Let’s also remember that “Compassionate Use” requires the company to give the product at no charge. Common sense as well as a look at Dendreon’s financial SEC statements for a company with no Sales income should make it evident that they simply cannot give their product away at no charge AT THIS TIME.
I am the recipient of free drugs from several major pharmaceutical company’s, but it is because they are selling their product to those who have the resources to pay… which I do not.
It is more than gratifying to see patients, physicians and those interested in seeing prostate cancer treatments which are more viable and offer the potential for better QoL for patients to be proactive in letting the FDA, Congress, media and others learn of this new immunotheraphy and how it helps PCa patients NOW!
Let’s continue to press for earlier Conditional Approval to get this product in the hands of those who need it NOW allowing DNDN more data from which to seek final Approval from the FDA.
Thank You! to those acting positively for the benefit of PCa patients and Good Luck and Best Wishes to those patients; my prayers are with you and your families!
I believe in Provenge, but was denied access to a clinical trial in NYC. This was Feb. 10, 2009. Basically, the reason given was that I was not androgen independent, even though this should be irrelevant. I was diagnosed with aggressive PC on July 9th of 2008. Too late for surgery, hormone therapy would kill me, ditto for chemo and radiation.
Provenge should be made available to anyone with PC who would like to fight it without the morbidity of the standard ‘cut it out, burn it out, poison it out’ approach. I am still healthy, and want to stay that way. FDA, quit dragging your feet, and approve Provenge NOW for ALL stages of PC.
I understand your frustration and feel the same way. However, if the FDA does finally approve Provenge (we are supposed to know by May 1, 2010) the approval will be limited to men with androgen independent disease because that is the specific disease that the clinical trials evaluated. Over time, there is no reason to believe that some doctors will write “off label” prescriptions for Provenge, but there will be a serious question about insurance coverage. Dendreon, the bio-tech company that has developed Provenge still has not announced any pricing data. Many of us believe that the three courses of treatment that the protocol requires will cost between $85,000 and $150,000, but this is pure speculation.
We hope to see some clinical trials of Provenge in the near future for men with hormone responsive disease, but I am not optimistic that these trials will begin for another two years, at the soonest. Dendreon, if they receive approval, will be struggling to meet the initial demand from men with hormone refractory disease who meet the criteria, for at least two years. They have launched a massive building program in their plants in New Jersey, California and Georgia, but the construction will not be completed for at least another year or so.
There is phase I clinical trial looking at another immunologic therapy for prostate cancer and they are accepting men who are hormone dependent. Go to http://www.clinicaltrials.gov and search for: NCT00908258. I tried to get into this trial but was rejected because of a history of an autoimmune disease.