Magazine article Drug Topics

Options Put Squeeze on Prostate Cancer

Magazine article Drug Topics

Options Put Squeeze on Prostate Cancer

Article excerpt

This year, an estimated 219,000 men will hear the news that they have prostate cancer. About 27,000 men will die of the disease during the same time period. According to the American Cancer Society, prostate cancer accounts for 9% of cancer deaths in men, second only to lung cancer. Although the five-year survival rate is close to 100% when the cancer is detected early, advanced cases still offer challenges and the need for new treatment options remains a reality. Here are a few new entities on the horizon.

*The Food & Drug Administration's Office of Cellular, Tissue, and Gene Therapies Advisory Committee reviewed Dendreon Corp.'s Biologies License Application (BLA) for sipuleucel-T (Provenge) on March 29, and it has voted in favor of the therapy based on available safety and efficacy data. If approved, sipuleucel-T will be the first active cellular immunotherapy and the first biologic approved for treating prostate cancer, according to the manufacturer. The agent works by targeting the prostatic acid phosphatase (PAP) antigen, which is present in about 95% of all prostate cancers.

Efficacy of the therapy was proven in a phase III study of 127 patients with metastatic androgen-independent prostate cancer who were given sipuleucel-T or placebo every two weeks until death or progression. The results showed 34% survival at 36 months for the sipuleucel-T arm compared with 11% receiving placebo. The median prostate-specific survival was 35.2 months for patients receiving sipuleucel-T compared with 23.5 months for those on placebo. Results for this study were published in the July 2006 issue of the Journal of Clinical Oncology.

Dendreon completed the BLA submission for sipuleucel-T in November 2006, and the FDA accepted the filing and granted priority review of the agent this past January. According to the company, an FDA decision is expected by mid-May.

*DCVax-Prostate, from Northwest Biotherapeutics, is in phase III of development. It is an autologous cellular therapy that utilizes a patient's own dendritic cells (DC) and a target protein called prostate-specific membrane antigen (PSMA)-expressed in all prostate cancers-to achieve an immune response. As part of the treatment, patient blood cells are shipped to a manufacturing facility in order to prepare the therapy. The dendritic cells are generated from monocytes obtained through leukapheresis. …

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