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The FDA has accepted a biologics license application for the investigational erythroid maturation agent luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, as well as for adult patients with beta-thalassemia-associated anemia who require RBC transfusions.

The FDA approved a supplemental new drug application to update the label for gilteritinib to include final analysis data from the phase III ADMIRAL trial, which demonstrated an improvement in overall survival with the FLT3 inhibitor compared with salvage chemotherapy in adult patients with relapsed/refractory FLT3-mutant acute myeloid leukemia.

Therapy for patients with multiple myeloma encompasses many agents and potential combinations, but truly personalizing care will require knowing how those agents interact for maximum efficacy and incorporating patient preferences for toxicity into the care plan.

The FDA has approved a supplemental new drug application for ivosidenib as a single agent for the first-line treatment of adult patients with IDH1-mutant acute myeloid leukemia, as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy.

A marketing authorization application has been submitted to the European Medicines Agency for luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndrome–associated anemia with ring sideroblasts who require red blood cell transfusions and have not received or are ineligible to receive erythropoiesis-stimulating agents.