The US Food and Drug Administration is asking its Oncologic Drugs Advisory Committee to take into consideration three factors in deciding whether future approvals in the phosphatidylinositol 3-kinase (PI3K) inhibitor class should be based upon randomized data.
PI3K Inhibitors: Overall Survival, Adverse Events And Dose Optimization Top US FDA’s Concerns
Agency will ask its Oncologic Drugs Advisory Committee whether future approvals in the class should be supported by randomized data, instead of single-arm studies, given potential overall survival detriment seen in randomized trials to date for four drugs.
