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.
Clinical Trials Advisor