Zytiga Pre-chemo Data Impress At ASCO, But Early Trial Termination Could Be An Issue

Data from a Phase III trial of Johnson & Johnson’s blockbuster prostate cancer drug Zytiga, which was halted for efficacy in March, were released June 2 at ASCO, but at least one expert in the field questions whether the risk to the eventual clinical results was worth it.

CHICAGO–Data from a trial of Johnson & Johnson’s blockbuster prostate cancer drug Zytiga (abiraterone) in asymptomatic or mildly symptomatic chemotherapy-naïve patients was received with widespread enthusiasm at the American Society of Clinical Oncology annual meeting, but they also raise some concerns about trial design and statistics that likely will raise flags at FDA and draw an advisory committee review.

Results from the Cougar-302 trial, which was stopped after an interim analysis showed significant improvement in progression-free survival for the...

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