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FDAnews Drug Daily Bulletin
June 28, 2012 | Vol. 9 No. 127
Experts Debate Early Trial Stoppage for J&J’s Supplemental Zytiga Apps
Experts are wondering whether Johnson & Johnson (J&J) made the right decision when it unblinded its pivotal trial for a supplemental indication for prostate cancer treatment Zytiga before the study met its overall survival endpoint. J&J announced June 15 it had submitted supplemental marketing applications to the FDA and European Medicines Agency for the cancer drug for use following failed androgen deprivation therapy but before chemotherapy.
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