Roche Outlines Use Of Real-World Evidence In Entrectinib NDA

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 acquired Flatiron, an oncology-focused electronic health records company, in 2018. The potential of Flatiron data to generate real-world evidence was highlighted at Roche’s ASCO event last year, where then-CEO...