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

 
• By Bridget Silverman

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 – to make regulatory decisions only a handful of times

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Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
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Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
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Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
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