San Diego—The FDA issued a boxed warning for differentiation syndrome for two isocitrate dehydrogenase (IDH) inhibitors recently approved to treat acute myeloid leukemia (AML)—enasidenib and ivosidenib. A potentially fatal complication associated with a broad array of clinical manifestations, including dyspnea and acute renal injury, differentiation syndrome may occur in up to 20% of patients taking these drugs, according to data on file with the FDA.
Differentiation syndrome was