FDA approves new treatment option for advanced prostate cancer

The FDA on April 29 announced the approval of sipuleucel-T (Provenge, Dendreon Corp.) for the treatment of certain men with prostate cancer, marking the first approval of a vaccine to treat cancer.

The approval for the treatment of men with advanced metastatic prostate cancer who were not responding to hormone therapy was based on the results of an IMPACT study, according to U.S. regulators. The trial, which involved 512 men, demonstrated that patients randomized to receive treatment with sipuleucel-T lived a median of 25.8 months, compared with 21.7 months among those who did not receive the treatment.

Karen Midthun, acting director of FDA’s Center for Biologics Evaluation and Research, said the autologous cellular immunotherapy “provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available.”

As a component of a post-marketing requirement, Dendreon will conduct a registry of about 1,500 patients to evaluate the risk of cerebrovascular events. In four randomized clinical trials, such events were observed in 3.5% of patients given sipuleucel-T, compared with 2.6% of patients in the control arms.

Mitchell Gold, CEO of Seattle-based Dendreon, said the approval marks the company’s transformation into a commercial enterprise. The company will begin manufacturing the drug at a plant in New Jersey, and it is expanding plants in Georgia and California to accommodate added production.