ZYTIGA Receives FDA Approval For Label Update For Prolonged Survival In Metastic Castration-Resistant Prostate Cancer

ZYTIGA Receives FDA Approval For Label Update For Prolonged Survival In Metastic Castration-Resistant Prostate Cancer
shutterstock_217644481ZYTIGA received approval from the U.S. Food and Drug Administration (FDA) for a label update on March 30, 2015. The approval was based on the results of a Phase 3 clinical study showing the drug could prolong median overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC). ZYTIGA was approved in the U.S. in 2011, and since then more than 150,000 prostate cancer patients worldwide have been prescribed the therapy. The new results suggest that patients with mCRPC should be prescribed ZYTIGA in combination with prednisone for the treatment of their prostate tumor. Prostate tumor cells develop adaptive mechanisms such as the capacity to produce androgen, which promotes their proliferation. Lowering androgens such as testosterone (androgen-deprivation therapy) is a treatment option to control prostate cancer growth. However, many patients develop metastasis and become resistant to this type of therapy, therefore requiring additional treatments to control cancer cell growth. The clinical trial, sponsored by Janssen, included 1,088 men and found that ZYTIGA combined with prednisone significantly prolonged OS (34.7 months) in comparison to placebo plus prednisone treated patients (30.3 months) in men who had not previously undergone chemotherapy (chemotherapy-naïve). "The statistically significant improvement in overall survival demonstrated in the final analysis and resulting label update help affirm
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