The Food and Drug Administration (FDA) has posted a Drug Safety Communication warning that clinical trial results have shown an increased risk of death associated with the phosphoinositide 3-kinase (PI3K) inhibitor duvelisib (Copiktra) compared with the monoclonal antibody ofatumumab in the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior unsuccessful therapies. The trial also showed that duvelisib was associated with a higher rate of serious and potentially fatal adverse effects (such as infections, diarrhea, inflammation of the intestine and lungs, skin reactions, and elevated liver enzymes). The adverse effects may be a class effect of PI3K inhibitors.

Upon approving duvelisib in 2018, the FDA required that the drug manufacturer, Secura Bio, conduct additional long-term follow-up studies to gain more information about survival and the risk of death related to duvelisib use. The Drug Safety Communication is based on the final analysis of overall survival at five years. The agency is continuing to review these data and may make additional changes to duvelisib's labeling in the future.

PI3K inhibitors cause cell death, inhibit the proliferation of malignant cells, and interfere with several signaling pathways. For information on a recently recalled PI3K inhibitor, see PI3K Inhibitor for Lymphoma Withdrawn from the Market.

Nurses should monitor patients prescribed duvelisib for signs of adverse effects and report any to the prescriber. Nonhospitalized patients receiving duvelisib should report signs of infection or other adverse effects immediately to their provider. Nurses or patients should report any adverse effects to the FDA's MedWatch program at http://www.accessdata.fda.gov/scripts/medwatch. (To learn how MedWatch report data are evaluated, see What Happens After a MedWatch Report Is Submitted to the FDA?)

Box 1. PI3K Inhibitor for Lymphoma Withdrawn from the Market

To read the Drug Safety Communication about duvelisib, go to http://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-possible-i.

Box 2. What Happens After a MedWatch Report Is Submitted to the FDA?