ODAC votes unanimously in support of use of randomized data in PI3K inhibitor trials

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On April 21, the FDA Oncologic Drugs Advisory Committee voted unanimously—with 16 “yes” votes and one abstention—to affirm that randomized data are warranted with an assessment of overall survival to support the evaluation of benefit-risk of phosphoinositide 3-kinase (PI3K) inhibitors in patients with hematologic malignancies.

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