The US Food and Drug Administration’s external experts on 21 April backed the agency’s view that future approvals of phosphatidylinositol 3-kinase (PI3K) inhibitors for hematological malignancies should be based on randomized, rather than single-arm, studies.
PI3K Inhibitors For Hematology Indications Need Randomized Data, FDA Panel Says
Vote can be seen as an endorsement of the Oncology Center of Excellence’s push for use of a single, ongoing randomized trial to serve as the basis for both accelerated approval and confirmatory evidence. OCE director Richard Pazdur says agency will be flexible in applying randomization requirements to future drugs that have a cleaner safety profile.
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