US FDA May Prioritize Pediatric Cancer Studies By Level Of 'Substantial Relevance'
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.
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Beginning in August 2020, applications for some novel cancer drugs and biologics will have to include reports on molecularly targeted pediatric investigations; agency is already working with sponsors on pediatric study development plans and expects to issue two draft guidances soon.
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.
Agency is working with manufacturers, including Takeda and Emergent BioSolutions, to accelerate development of hyperimmune globulin products, with an eye toward starting clinical testing in several months; new FDA guidelines on convalescent plasma collection for single-patient emergency IND use are helpful in understanding agency expectations around source plasma collection for manufactured products as well, Emergent SVP Laura Saward says.