Our friend in Israel, Lenny Hirsch, has been fighting a lonely battle to try to get the health plan in his country to provide men with advanced prostate cancer a chance to receive Taxotere (docetaxel). Taxotere is the only chemotherapy drug so far proven to extend the lives of men with advanced metastatic prostate cancer. In Israel and in some European countries many men are not diagnosed until the disease has already spread outside the prostate — and then, as Lenny describes in his article “Sad Day,” they are not even able to receive chemotherapy.

Well, it’s no better in Scotland. Prostate cancer affects one in 15 men in Scotland. It is the UK’s most common form of male cancer and in the UK it has a much higher death rate than in the USA. It affects more than 30,000 UK men each year, killing 10,000 - at least one per hour. Now men in Scotland suffering from advanced prostate cancer have been told they cannot receive Taxotere.

“Men in Scotland with prostate cancer will not receive a life-prolonging drug on the NHS because it is too expensive,” BBC reports. They mean Taxotere.
(full story…)

Dendreon Announces FDA Grants Fast Track Status for Provenge

Earlier:
Dendreon’s Phase 3 Trial Shows Provenge Vaccine Extends Survival in Patients with Advanced Prostate Cancer Oct 28, 2004

Meanwhile in Europe:
Dendreon’s Second Randomized Phase 3 D9902A Trial of Provenge Extends Survival in Patients with Advanced Prostate Cancer

PARIS, FRANCE, October 31, 2005 – Dendreon Corporation (Nasdaq: DNDN) today announced that final results of its second Phase 3 study (D9902A) of PROVENGE® (sipuleucel-T), the Company’s investigational active cellular immunotherapy for the treatment of prostate cancer, were presented here today during a late-breaking clinical trials session at ECCO 13-the European Cancer Conference. Researchers concluded that these results are consistent with the results from the Company’s first Phase 3 study (D9901). The Company recently announced plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to market PROVENGE based on discussions of these data with the FDA.

“The combined data from the trials of PROVENGE versus placebo demonstrate that active immunotherapy favorably impacts survival in men with asymptomatic, metastatic, androgen-independent prostate cancer,” reported Celestia S. Higano, M.D., director and associate professor of the Genitourinary Oncology Clinical Research Group at the University of Washington, Seattle, who presented the data. “Given the favorable side effect profile, PROVENGE may provide a useful alternative for men prior to initiating chemotherapy.”
Study Results
(full story…)