FDA questions validity/reproducibility of AstraZeneca's olaparib efficacy data
This article was originally published in Scrip
Executive Summary
While a single study of AstraZeneca's investigational drug olaparib demonstrated positive results of an 83% reduction in the risk of progression or death and a seven-month median improvement in maintenance progression-free survival (PFS) for patients with platinum-sensitive germline BRCA mutation (gBRCAm)-associated ovarian cancer, the FDA said there were uncertainties about the validity and reproducibility of the magnitude of effect in the trial.