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U.S. FDA Approves Expanded ZYTIGA® Indication For Treatment Of Metastatic Castration-Resistant Prostate Cancer

HORSHAM, Pa., Dec. 10, 2012 /PRNewswire/ -- 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.

"Over and over, I hear how devastating it is when men and their families learn their metastatic prostate cancer has progressed despite treatment," said Thomas Farrington, president and founder, Prostate Health Education Network (PHEN), a national organization committed to increasing prostate health education and awareness.  "I believe having ZYTIGA as a new therapeutic option before chemotherapy will provide hope for patients with metastatic castration-resistant prostate cancer and their families as they continue to battle the disease."

Janssen Research & Development previously announced that an Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding the Phase 3, randomized, double-blind, placebo-controlled, international study, COU-AA-302, after planned interim analyses found a statistically significant difference in radiographic progression-free survival (rPFS), and median overall survival (OS) for ZYTIGA was longer than the placebo group.  Based on these results, the IDMC also recommended that patients in the control arm be offered treatment with ZYTIGA.

"We are delighted ZYTIGA is now approved for men with metastatic castration-resistant prostate cancer earlier in the course of their disease, before chemotherapy, where there continues to be a need for additional treatment options," said Robert Bazemore, president, Janssen Biotech, Inc.  "We're dedicated to delivering therapeutic options with exceptional services.  ZYTIGAOne™ is our one-to-one support for ZYTIGA, to help make access simple and convenient."

Additional Details from the COU-AA-302 StudyThe approval is based on a supplemental New Drug Application (sNDA) that included efficacy and safety results of a Phase 3, randomized, double-blind, placebo-controlled international clinical study, which evaluated ZYTIGA plus prednisone compared to placebo plus prednisone in 1,088 men with mCRPC who had failed androgen deprivation therapy and had not received cytotoxic chemotherapy.

Patients were randomized either to receive ZYTIGA 1,000 milligrams (mg) administered orally once daily plus prednisone 5 mg administered twice daily or placebo plus prednisone 5 mg administered twice daily.  The co-primary endpoints of the study are radiographic progression-free survival (rPFS) and overall survival (OS).  

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