PI3K Inhibitor Fails to Pass Muster With FDA Advisory Committee
The FDA’s Oncologic Drugs Advisory Committee (ODAC) made a clean sweep of its 2-day meeting, deciding that the PI3K inhibitor duvelisib (Copiktra) does not offer a favorable risk-benefit ratio for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). By an 8-4 vote, the panel came down on the side of the FDA […]