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EC approves blinatumomab as consolidation for adult patients with newly diagnosed Ph− CD19+ B-ALL
On January 29, 2025, the European Commission (EC) approved blinatumomab, a bispecific T-cell engager, as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome-negative (Ph−) CD19+ B-cell acute lymphoblastic leukemia (B-ALL).1
This approval was based on results from the phase III, randomized, controlled ECOG-ACRIN E1910 trial (NCT02003222) assessing the safety and efficacy of consolidation chemotherapy with or without blinatumomab in patients aged 30–70 years with newly diagnosed Ph− B-ALL in measurable residual disease (MRD)-negative remission.1,2 Results from this trial were previously covered by the ALL Hub. Briefly:
- The primary endpoint was met: after a median follow-up of 43 months, the 3-year overall survival (OS) rate was 85% in the blinatumomab plus chemotherapy arm vs 68% in the chemotherapy-alone arm.2
- After a median follow-up of 4.5 years, the 5-year OS rate was 82.4% in the blinatumomab plus chemotherapy arm vs 62.5% in the chemotherapy-alone arm.1
- The safety profile was consistent with the known safety profile of blinatumomab.1
Blinatumomab is now indicated as a treatment for the following patients in the EU1:
- Adult patients with CD19+ relapsed or refractory B-ALL. Patients with Ph+ B-ALL should have failed treatment with ≥2 tyrosine kinase inhibitors and have no alternative treatment options.
- Adult patients with Ph- CD19+ B-ALL in first or second complete remission with MRD ≥0.1%.
- Pediatric patients aged ≥1 years with Ph- CD19+ B-ALL which is refractory or in relapse after receiving ≥2 prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
- Pediatric patients aged ≥1 years with high-risk first relapsed Ph− CD19+ B-ALL as part of the consolidation therapy.
- Adult patients with newly diagnosed Ph− CD19+ B-ALL, as part of consolidation therapy.
On June 14, 2024, blinatumomab was also approved by the U.S. Food and Drug Administration as a consolidation therapy for adult and pediatric patients with Ph− CD19+ B-ALL, irrespective of MRD status.
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