FDA Approval Summary: Blinatumomab for the Treatment of B-cell Precursor Acute Lymphoblastic Leukemia in the Consolidation Phase of Multiphase Chemotherapy.

ABSTRACT: On June 14, 2024, the FDA approved blinatumomab (Blincyto; Amgen, Inc) in the consolidation phase of treatment for CD19-positive, Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (BCP ALL). FDA reviewed results from three randomized trials using blinatumomab in consolidation: Study E1910 (adult patients with newly diagnosed BCP ALL without minimal residual disease), Study 20120215 (pediatric patients with high-risk BCP ALL in first relapse), and Study AALL1331 (pediatric and young adult patients with BCP ALL in first relapse). Study E1910 demonstrated a significant improvement in overall survival (OS) when comparing alternating blinatumomab and chemotherapy cycles versus chemotherapy cycles alone (HR 0.42; 95% CI 0.24, 0.75; p = 0.003). In Study 20120215, the

SUBMITTER: Rabik CA 

PROVIDER: S-EPMC12367060 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature