What happened to the Provenge (Sipuleucel-T) vaccine for hormone refractory prostate cancer?
The preliminary data appeared promising for men with hormone refractory prostate cancer (HRPC). The Food and Drug Administration advisory panel voted 13 to 4 to approve Provenge (sipuleucel-T) and the same panel voted 17 to 0 that it was safe. However, several weeks later the vaccine was not approved. Why did this happen? Why wasn't this novel therapy at least given "provisional" approval status, which simply allows dying patients to receive the medication until the results of the next phase III trial are known? Patients need more options for HRPC because some of the most popular current choices for HRPC were never even FDA approved, but it seems clinicians and patients are desperate for more choices so they are willing to attempt almost any intervention to improve the quality and quantity of life. Regardless, the situation with Provenge is disappointing and should be re-evaluated.
University of Michigan Medical Center, Department of Urology, Ann Arbor, MI, USA.
Mark A
MA
Moyad
D019496:Cancer Vaccines; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000458:organization & administration*; D006301:Health Services Needs and Demand; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000628:therapy*; D014020:Tissue Extracts; D014481:United States; D014486:United States Food and Drug Administration
D019496:Cancer Vaccines; D014020:Tissue Extracts; C511774:sipuleucel-T