Pediatric Cancer Studies: US FDA’s Molecular Target Lists Face Panel Vetting
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.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Assessing the extent of a molecular target's substantial relevance to pediatric cancer could give sponsors more regulatory certainty as to whether they likely would be required to conduct pediatric investigations early in a drug’s development, US FDA's Gregory Reaman says at advisory committee review of molecular target candidate lists.
Initial draft list of molecular target candidates has industry, investigators and patient advocates asking how the agency intends to prioritize targets and same-in-class molecules for pediatric studies, and how frequently it will update the list; industry representatives divided as to whether ‘broader is better’ when it comes to the target list.