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The combination of acalabrutinib (Calquence) and obinutuzumab (Gazyva) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with obinutuzumab/chlorambucil in patients with previously untreated chronic lymphocytic leukemia, meeting the primary endpoint of the phase III ELEVATE-TN trial.

Ixazomib in combination with dexamethasone did not demonstrate a significant improvement in overall hematologic response compared with standard therapy in patients with relapsed/refractory systemic light-chain amyloidosis, missing one of two primary endpoints in the phase III TOURMALINE-AL1 trial and leading to discontinuation of the study.

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.