Roche turned to its Flatiron Health subsidiary to generate an external control arm of cancer patients with ROS1 mutations to provide a comparator for pivotal single-arm trial data in the new drug application for entrectinib, Roche chief executive officer Bill Anderson told the company’s analyst event on 3 June at the American Society for Clinical Oncology annual meeting.
Roche Outlines Use Of Real-World Evidence In Entrectinib NDA
Roche used its Flatiron Health oncology EHR database to generate an external control arm for pivotal single-arm data supporting the personalized medicine candidate, which has an 18 August user fee goal.
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