Janssen receives FDA approval for ZYTIGA to treat metastatic castration-resistant prostate cancer

Published on December 10, 2012 at 11:06 PM · No Comments

Janssen announced today that the U.S. Food and Drug Administration (FDA) has approved a broader indication for the oral, once-daily medication ZYTIGA® (abiraterone acetate). Until now, ZYTIGA with prednisone has only been approved to treat men with metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel. With this approval, ZYTIGA, in combination with prednisone, may now be used earlier in the treatment continuum for metastatic castration-resistant disease, before the use of chemotherapy.

ZYTIGA also received a positive opinion for an expanded indication from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is under review by other health authorities worldwide.

"This expanded indication for ZYTIGA helps fill a critical medical need, providing physicians an important tool for treating men with metastatic castration-resistant prostate cancer who have not received chemotherapy," said Charles J. Ryan, M.D., associate professor of clinical medicine at the UCSF Helen Diller Family Comprehensive Cancer Center and lead investigator of the pivotal Phase 3 study on which this approval is based.  "ZYTIGA works by inhibiting the enzyme complex required for the production of androgens in the testes, adrenals and the prostate tumor tissue."

Excluding skin cancer, prostate cancer is the most frequently diagnosed cancer in men in the U.S.  In 2012, the American Cancer Society estimates more than 28,000 men will die from the disease, making it the second leading cause of cancer death behind lung cancer. There are approximately 35,000 new cases of mCRPC each year.

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