FDA’s Cancer Advisory Committee to Evaluate Safety of PI3K inhibitors

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers. Dysregulated PI3K signaling helps malignant lymphocytes survive and proliferate. The FDA is essentially asking the advisory committee to make a recommendation on whether future approvals for this class of drug should be based on randomized data instead of single-arm clinical trials.