A decade of FDA approvals for pediatric cancer indications: What have we learned?

EJC Paediatric Oncology（2023）

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摘要

•29 cancer drugs received FDA approval for 39 pediatric indications from 2012 to 2021.•Few approvals were attributable to legislative initiatives.•Sponsors frequently leveraged RWD and/or pediatric extrapolation in development.

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关键词

Pediatric drug development,Pediatric cancer,Regulatory,Real-world data,Pediatric extrapolation

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