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U.S. FDA approves blinatumomab as consolidation for adult and pediatric patients with CD19+ B-ALL, irrespective of MRD status

Jun 17, 2024
Learning objective: After reading this article, learners will be able to cite a new clinical development in ALL.

On June 14, 2024, the U.S. Food and Drug Administration (FDA) approved blinatumomab for the treatment of adult and pediatric patients aged 1 month or older who have CD19-positive, Philadelphia chromosome (Ph)-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase of multiphase chemotherapy, irrespective of measurable residual disease status.1 The decision is based primarily on data from the ECOG-ACRIN E1910 study (NCT02003222), a phase III randomized, controlled trial in adult patients with newly diagnosed, Ph-negative B-ALL, as well as data from study 20120215 (NCT02393859), a randomized, controlled, open-label, multicenter trial including pediatric and young adult patients with Ph-negative BCP ALL.1

Key data

In the ECOG-ACRIN E1910 study, eligible patients in hematologic complete remission (CR) or CR with incomplete peripheral blood count recovery (CRi) following induction and intensification chemotherapy were randomized 1:1 to receive a consolidation regimen of multiple blinatumomab monotherapy cycles plus multiple cycles of intensive chemotherapy (n = 112) or intensive chemotherapy alone (n = 112).1

  • Addition of blinatumomab to multiphase consolidation chemotherapy resulted in superior overall survival (OS) vs chemotherapy alone; 3-year OS was 84.8% (95% confidence interval [CI], 76.3–90.4) vs 69% (95% CI, 58.7–77.2) in the blinatumomab and chemotherapy arms, respectively.
  • At a median follow-up of 4.5 years, the 5-year OS was 82.4 % (95% CI, 73.7–88.4) in the blinatumomab arm and 62.5 % (95% CI, 52.0–71.3) in the chemotherapy arm.

In study 20120215, patients aged >28 days and <18 years were randomized 1:1 to receive blinatumomab or the IntReALLHR2010 HC3 intensive combination chemotherapy as the third consolidation cycle.1

  • The 5-‑year OS was 78.4% (95% CI, 64.2–87.4) vs 41.4% (95% CI, 26.3–55.9) for the blinatumomab and chemotherapy arms, respectively.
  • The 5-year relapse-free survival was 61.1% (95% CI, 46.3–72.9) with blinatumomab and 27.6% (95% CI, 16.2–40.3) with chemotherapy.


This FDA approval marks an important clinical development for this patient population, allowing treatment with blinatumomab irrespective of MRD status, redefining the standard of care for patients with B-ALL.1,2

  1. U.S. Food & Drug Administration. FDA approves blinatumomab as consolidation for CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia. Published Jun 14, 2024. Accessed Jun 17, 2024.
  2. OncLive. FDA approves blinatumomab for CD19+ B-ALL in the consolidation Phase. Published Jun 14, 2024. Accessed Jun 17, 2024.


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