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Blinatumomab receives FDA approval for MRD+ Philadelphia negative B-ALL

Jun 23, 2023
Learning objective: After reading this article, learners will be able to cite a new clinical development in ALL.

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Blinatumomab was initially granted accelerated approval in March 2018 for patients with B-cell precursor acute lymphoblastic leukemia (B-ALL) who had received three blocks of prior chemotherapy, were in hematologic complete remission, and had MRD ≥0.1%1. This was based on data from the BLAST clinical trial (NCT01207388) which demonstrated an 18-month relapse-free survival (RFS) rate of 56% and an estimated median RFS of 22.3 months. Blinatumomab has now been granted full approval following support from both BLAST and ECOG-ACRIN E1910 (NCT02003222) phase III clinical trials.1


BLAST was an open-label single-arm trial including 86 patients with B-ALL. Undetectable MRD was achieved in 81.4% (95% confidence interval [CI], 71.6%–89.0%) with a sensitivity of 0.01% for 6 patients and ≥0.005% for 80 patients in the whole population.2 The estimated hematological RFS was 24.2 months.


ECOG-ACRIN E1910 is a phase III randomized trial investigating 488 adult patients (aged 30–70 years) with newly diagnosed Philadelphia negative B-ALL.3 Among the MRD-negative patients (n = 224), median OS was not reached in patients treated with blinatumomab and chemotherapy versus 71.4 months with chemotherapy treatment alone (HR, 0.42; 95% CI, 0.24-0.75).


Additional data from these two clinical trials demonstrated the clinical benefit of blinatumomab for patients with B-ALL who had MRD ≥0.1%; this supported the conversion from accelerated approval to full approval for blinatumomab.1

  1.  FDA grants full approval for blincyto® (blinatumomab) to treat minimal residual disease-positive b-cell precursor acute lymphoblastic leukemia. Published Jun 21, 2023. Accessed Jun 22, 2023.
  2.  Blinatumomab. Package insert. AMGEN; 2023.
  3. Litzow MR. Consolidation therapy with blinatumomab improves overall survival in newly diagnosed adult patients with B-lineage acute lymphoblastic leukemia in measurable residual disease negative remission: results from the ECOG-ACRIN E1910 randomized phase III National Cooperative Clinical Trials Network trial. Oral abstract #S115. 64th American Society of Hematology Annual Meeting and Exposition; December 13, 2022; New Orleans, US.

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Which of the following treatment options would you select for a patient with a high disease burden of relapsed/refractory Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia?
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