Un pò di storia........qui il rimando è stato il 9 maggio 2007....per la serie FDA fa come caxxo vuole e gioca con i malati di cancro alla prostata come il gatto col topo.......Non ha neppure seguito la votazione degli esperti favorevoli all'unanimità...uno scandalo che ci sia di monito !!!
In his 18 February 2005 column in
Forbes magazine, Scott Gottlieb, who later served as a top policy maker with the FDA until early 2007,[
citation needed] argued for Provenge approval: "That 4.5-month increase in survival is almost double the 2.5-month benefit shown in clinical trials of
Taxotere, a drug that is the next best thing for patients like those in the Provenge trial whose cancer has spread beyond the prostate gland and is no longer being controlled by
hormonal therapy."
[11]
In 2006, the company built a manufacturing facility in
Morris Plains, New Jersey to accommodate Provenge production in anticipation of possible approval by the
U.S. Food and Drug Administration (FDA) in 2007, as well as for production for a Phase III trial, IMPACT (previously known as D9902B).
[12]
In January 2007, the FDA accepted Dendreon's
Biologics License Application filing for Provenge, with an FDA decision due by May 15, 2007.
[13]
The FDA Office of Cellular, Tissue and Gene Therapies Advisory Committee on 29 March 2007 voted 17-0 that Provenge is reasonably safe and 13-4 that the trial data showed substantial evidence that it is effective.
[14] The FDA set a
PDUFA date of May 15, 2007 as its deadline to decide whether or not to grant approval to Provenge; it was not bound to accept the recommendation of the advisory committee.
[15]
On May 9, 2007 DNDN dropped to just over $7 per share when the company received a letter from the FDA demanding more results and information before approval.
[16] The Seattle Times reported that layoffs are likely and quoted an industry analyst as saying that Dendreon will probably lay off half of its current workforce of 250.
[17] Mark Thornton described this "in the annals of cancer
immunotherapy as Black Wednesday" as, within an eight-hour period the "FDA succeeded in killing not one but two safe, promising therapies"–
Provenge, and also
Junovan (for
Osteosarcoma treatment).
[18]
On December 13, 2007 three US congressmen,
Mike Michaud (D-Maine),
Dan Burton (R-Indiana) and
Tim Ryan (D-Ohio), requested a probe into the FDA's delay in approving Provenge and conflicts of interest held by certain advisory committee members.
On March 12, 2008 the FDA said they would accept results a year early, boosting the stock price 10%.[
citation needed]
On October 6, 2008, Dendreon CEO Mitchell Gold released the results of the Phase 3 IMPACT interim report which stated this midterm result missed by only 2% from the desired result. However, due to the late acting nature of the treatment, he was confident that Provenge will reach the desired 22% survival rate by final test results in mid 2009. On this news, stock price rose 65% before falling back down in subsequent days to the normal trading range.
[19]
On April 14, 2009, it was announced that the results for the definitive Phase 3 trial of Provenge were positive. According to the
New York Times,though, "The lack of details from Dendreon Tuesday leaves some uncertainty about how well Provenge really worked." There had been a reduction in the odds of death compared to the use of a
placebo. The trial involved about 500
prostate cancer patients who were no longer benefiting from therapies intended to deprive the
tumors of
testosterone.
[20]
At the American Urological Association
[1] meeting on April 28, 2009, the details of the Phase 3 IMPACT study were released. The primary endpoint of this study was overall survival. The trial showed that patients treated with Provenge (generic name Sipuleucel-T) lived an average of 4.1 months longer than those patients treated with the control (autologous cells without the GM-CSF / PAP fusion protein). The hazard ratio was 0.775 (95% CI: 0.614, 0.979) and the p value was statistitically significant (p=0.032, Cox model). Based on this trial, Dendreon plans to submit an amendment to their BLA by mid-November
[2].