Real-World Evidence At US FDA: Bavencio, Blincyto Approvals Point Way Toward Broader Use

Breakthrough-designated oncologics used historical comparator data to determine efficacy threshold for pivotal Phase II studies supporting accelerated approval; Blincyto’s subsequent full approval offers validation with conventional controlled study. 

Drug Review Profile regular column

The US FDA’s approvals of Amgen Inc.’s Blincyto and EMD Serono Inc./Pfizer Inc.’s Bavencio using external control arms could mark a tipping point in the regulatory use of real-world evidence (RWE).

FDA has turned has turned to RWE – mostly in the form of historical control arms or case studies –...

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