Posted on May 4th, 2011 by
The US Food and Drug Administration (FDA) has approved Zytiga™ (abiraterone acetate) for the treatment of advanced prostate cancer. The approval came two months earlier than expected.
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.
A study that contributed to the approval of Zytiga enrolled 1,195 men from 13 countries. The study participants had metastatic, hormone-refractory prostate cancer that has progressed after chemotherapy. Patients were treated with either Zytiga plus prednisone or prednisone alone. Zytiga improved overall survival by four months (overall survival was 15 months in the group that received Zytiga and 11 months in the group that did not receive Zytiga).
The most common side effects of Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention, muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion, and upper respiratory tract infection.
Zytiga was approved in combination with prednisone for the treatment of metastatic, hormone-refractory prostate cancer that has previously been treated with chemotherapy.
The approval of Zytiga provides an additional treatment option for men with advanced disease.
Reference: FDA news release. FDA approves Zytiga for late-stage prostate cancer. April 28, 2011.
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