The U.S. Food and Drug Administration (FDA) issued a warning for duvelisib because of a possible increased risk of death and serious adverse events (AEs). Duvelisib is a phosphatidylinositol 3 (PI3) kinase inhibitor that was approved in 2018 for chronic lymphocytic leukemia or small lymphocytic leukemia after at least two prior lines of therapy.
The warning was based on the results from the phase III DUO trial conducted by the manufacturer. Five-year survival data showed a possible increased risk of death and a higher rate of serious AEs such as elevated liver enzyme levels in the blood, infections, diarrhea, skin reactions, and inflammation of the intestines and lungs.
“These safety findings were similar for other medicines in the same PI3 kinase inhibitor class,” the FDA stated.
The FDA further noted that patients should talk to their health care provider about the risks of continuing treatment with duvelisib and possible alternative options.
Source: FDA, June 30, 2022.
