FDA Approves Immunotherapy for Advanced Prostate Cancer

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The FDA has approved an immunotherapy that has been shown to improve survival of men with advanced prostate cancer.

The treatment, sipuleucel-T (Provenge), is designed to induce an immune response against prostatic acid phosphatase, an antigen expressed in most prostate cancers. Sipuleucel-T, which was developed by Dendreon Corp. of Seattle, is the first in a new therapeutic class known as autologous cellular immunotherapies.

Approval of the treatment “represents a significant scientific and clinical advancement for the treatment of prostate cancer,” said Philip Kantoff, MD, Director of the Lank Center for Genitourinary Oncology, Chief of the Division of Solid Tumor Oncology, and Chief Clinical Research Officer at Dana-Farber Cancer Institute in Boston. “Cancer immunotherapies that use the patient's own immune system will likely create an entirely new treatment paradigm for patients with cancer.”

In a press release, Dendreon said it intends to make sipuleucel-T available through about 50 centers.

The FDA approved the treatment on the basis of three phase 3 trials involving 737 patients. In one trial, sipuleucel-T extended median survival by 4.1 months compared with a control group (25.8 vs. 21.7 months). The therapy reduced the overall death risk by 22.5% compared with controls.

“Provenge offers a new choice in the front line treatment for these men who—until today—had few appealing treatment options,” said David Penson, MD, Professor of Urologic Surgery at Vanderbilt University Medical Center in Nashville, Tenn.

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