FDA approves Dendreon's Provenge for prostate cancer

The FDA on Thursday announced the approval of Dendreon's immunotherapy Provenge (sipuleucel-T) for the treatment of certain men with prostate cancer, marking the first approval of a vaccine to treat cancer. Shares in the company climbed 19 percent on the news.

US regulators said 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 the IMPACT study. The trial, which involved 512 men, demonstrated that patients randomised to receive treatment with Provenge lived a median of 25.8 months, compared to 21.7 months among those who did not receive the treatment.

Commenting on the drug, Karen Midthun, acting director of the 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 approximately 1500 patients to evaluate the risk of cerebrovascular events. In four randomised clinical trials, such events were observed in 3.5 percent of patients given Provenge, compared with 2.6 percent of patients in the control arms.

Dendreon CEO Mitchell Gold said the approval "marks Dendreon's transformation into a commercial enterprise, ready to support the successful launch of the first personalized treatment for cancer." He added that the company is ready to begin manufacturing the drug at a plant in New Jersey and is expanding two additional plants in Georgia and California that he says "will be on line by the middle of next year."

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