Genentech Wants Other Firms' Compounds For Mass Pediatric Cancer Screening
Master protocol for Phase I/II screening trial could make development more efficient, but concerns about regulatory obligations, lack of registrational intent and infrastructure complexity – as well as firms' willingness to share – may be hurdles to participation.
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Existing regulatory authorities could be optimized to speed development of promising pediatric cancer therapeutics, particularly those that don’t work in adult cancers.
Leukemia & Lymphoma Society worked with US FDA on umbrella trial strategy to accelerate development of new targeted therapies in molecularly-defined subsets of AML.