• By ICR Secretariat
  • Posted Monday, December 4, 2017

Bayer unblinds cancer drug study early to investigate patient deaths


"Dive Brief:

  • German drugmaker Bayer AG's efforts to expand use of its prostate cancer drug Xofigo hit a major safety setback Friday, after the company disclosed a Phase 3 study of the therapy would be unblinded early due to a higher number of patient deaths occurring in the treatment group than in the placebo arm.
  • An independent data monitoring committee flagged the imbalance, recommending Bayer analyze the new findings from the study, which pairs Xofigo with J&J's Zytiga and prednisone to treat castration-resistant prostate cancer that has metastasized to bones.
  • No patient in the Phase 3 trial is currently receiving Xofigo, as enrollment into the study completed in September 2016 and the drug is only administered for up to 6 doses over 24 weeks. Bayer said it had informed the relevant health regulators of the unblinding and plans to gather more detailed data on the new signal."

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