Prostate cancer "vaccine" faces hurdles

In May 2007, the FDA decided to withhold approval of sipuleucel-T (Provenge), a new type of prostate cancer drug that acts like a vaccine in that it aims to harness a man’s own immune system to fight his tumor. Preliminary studies had indicated the drug was promising in men with advanced prostate cancer who were no longer responding to hormone therapy, and in March 2007 an FDA advisory panel recommended that the drug be approved for marketing. But in May the FDA instead decided to issue an “approvable” letter, asking for more proof that the drug really works, as well as more information about how the drug will be manufactured. It is likely that it will take several more years to assemble the necessary information.

Source: Small EJ, Schellhammer PF, Higano CS, et al. Placebo-Controlled Phase III Trial of Immunologic Therapy with Sipuleucel-T (APC8015) in Patients with Metastatic, Asymptomatic Hormone Refractory Prostate Cancer. Journal of Clinical Oncology 2006;24:3089–94. PMID: 16809734.