June 10th, 2011

Zytiga Prolongs Survival with Advanced Prostate Cancer


Among men with hormone-refractory prostate cancer, treatment with Zytiga™ (abiraterone) improves overall survival by close to four months. These results—which contributed to the approval of Zytiga by the US Food and Drug Administration (FDA)—were published in the New England Journal of Medicine.

Prostate cancer is a hormonally sensitive disease that can often be controlled for long periods with androgen-deprivation therapy (ADT). When prostate cancer stops responding to this treatment, it is referred to as hormone-refractory prostate cancer. Metastatic hormone-refractory prostate cancer is a challenging form of the disease to treat because the cancer has spread to distant sites in the body and does not respond to treatment with standard hormonal therapy.

Zytiga, which is taken orally, blocks the production of androgens (male hormones such as testosterone) not only by the testes but also by the adrenal glands and the tumor itself.

The safety and efficacy of Zytiga were evaluated in a Phase III clinical trial of 1,195 men from 13 countries. The study participants had metastatic, hormone-refractory prostate cancer that has progressed (worsened) after chemotherapy. Patients were treated with either Zytiga plus prednisone or prednisone alone.

  • Zytiga improved overall survival by close to four months: overall survival was 14.8 months in the group that received Zytiga and 10.9 months in the group that did not receive Zytiga.
  • Side effects that were more common in the Zytiga group included fluid retention, high blood pressure, and low levels of potassium in the blood.

These results indicate that Zytiga can prolong survival among men with advanced prostate cancer.

Zytiga has been approved in combination with prednisone for the treatment of metastatic, hormone-refractory prostate cancer that has previously been treated with chemotherapy.

Reference: de Bono JS, Logothetis CJ, Molina A et al. Abiraterone and increased survival in metastatic prostate cancer. New England Journal of Medicine. 2011;364:1995-2005.

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Tags: News, Prostate Cancer, Refactory/Recurrent Prostate Cancer, Uncategorized