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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.

The combination of lenalidomide (Revlimid) with rituximab (Rituxan), cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; R2-CHOP) did not improve progression-free survival compared with placebo and R-CHOP as a frontline therapy in patients with activated B-cell-type diffuse large B-cell lymphoma, missing the primary endpoint of the phase III ROBUST trial.

Charles G. Mullighan, MBBS, MSc, MD, member, St. Jude Faculty, deputy director, Comprehensive Cancer Center, co-leader, Hematological Malignancies Program, medical director, St. Jude Biorepository, William E. Evans Endowed Chair, St. Jude Children’s Research Hospital, discusses germline predisposition to acute lymphoblastic leukemia (ALL).

A supplemental biologics license application has been submitted to the FDA 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 also for adult patients with beta-thalassemia–associated anemia who require such transfusions.

The FDA has added 3 months to the review period for a new drug application for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia, allowing the agency to review additional data provided by Daiichi Sankyo.