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Pediatric Cancer Studies: US FDA’s Molecular Target Lists Face Panel Vetting

 
• By Sue Sutter

In addition to reviewing proposed lists of targets for relevance to pediatric cancer, advisory committee will discuss possible criteria for prioritizing same-in-class agents for evaluation and ways to promote international collaboration and global development; proposed list of substantially relevant targets is growing.

Target hit in center by arrows. 3d illustration. Sunrise on background
A drug aimed at a molecular target that is substantially relevant to pediatric cancer might face additional studies under a recent US law.

A US FDA advisory committee’s views on the development and implementation of a list of pediatric cancer molecular targets also could influence how studies among multiple agents in the same class are prioritized and coordinated on a global basis.

The Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will meet June 20 to review FDA’s proposed lists of molecular targets considered to be substantially relevant, or not relevant,...

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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EU CHMP Opinions And MAA Updates

 
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