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Home » FDA AdCom Votes Nearly Unanimously to End Single-Trial Approvals for PI3K Inhibitors
FDA AdCom Votes Nearly Unanimously to End Single-Trial Approvals for PI3K Inhibitors
The FDA’s Oncologic Drugs Advisory Committee voted nearly unanimously (16 for and one abstaining) to require makers of phosphatidylinositol 3-kinase (PI3K) inhibitors in blood cancers to complete randomized phase 3 trials with active comparators before they submit applications for approval.