FDA Warns of Rare Lung Inflammation With Certain CDK 4/6 Inhibitors

Palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs, the U.S. Food and Drug Administration (FDA) announced on September 13, 2019. It approved new warnings about the risk on the prescribing information and package insert for the entire class of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. However, “the overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed,” the agency noted.