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Saturday, May 14, 2011

FDA Approves Abiraterone for Metastatic Prostate Cancer

The US Food and Drug Administration (FDA) has approved abiraterone acetate (Zytiga, Cougar Biotechnology) in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer in men who have received prior docetaxel chemotherapy.


The new drug targets the protein cytochrome P450 17A1 (CYP17A1), which plays an important role in the production of testosterone, according to the FDA. Abiraterone works by decreasing the production of testosterone, which stimulates prostate cancer cell growth.


In addition to the newly approved abiraterone, 2 other new agents have been approved for men with advanced prostate cancer in the past year.

Sipuleucel-T (Provenge, Dendreon) is an immunotherapy indicated for asymptomatic or minimally symptomatic men with castration-resistant metastatic prostate cancer. It improved overall survival duration by a median of 4.1 months compared with survival in a control group.
Candidates for this vaccine should have a good performance status, an estimated life expectancy of more than 6 months, and no visceral disease, according the 2011 National Comprehensive Cancer Network guidelines.
Another new second-line option in this setting — cabazitaxel (Jevtana, Sanofi-Aventis) — has also been shown in a phase 3 trial to prolong overall survival; median survival duration was 15.1 months in the cabazitaxel group and 12.7 months in the mitoxantrone group.
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