European Commission Approves Blinatumomab Consolidation for Philadelphia Chromosome–Negative CD19-Positive BCP-ALL

The European Commission has approved blinatumomab as consolidation therapy for patients with Philadelphia chromosome–negative, CD19-positive B-cell precursor acute lymphoblastic leukemia (BCP-ALL), according to a press release from Amgen, the developer of the drug.

The approval is based on results from the phase III E1910 clinical trial, in which blinatumomab added to multiphase consolidation chemotherapy demonstrated a superior five-year overall survival compared with chemotherapy alone (82.4% vs 62.5%, respectively).

“While there has been some treatment progress, many patients with newly diagnosed Philadelphia chromosome-negative B-ALL remain at high risk of relapse,” said Robin Foà, MD, emeritus professor of hematology at the Sapienza University of Rome, in the press release. “The E1910 study results highlight that [blinatumomab] has the potential to advance frontline consolidation treatment, including patients who are [measurable] residual disease-negative, offering a crucial new option to achieve deeper remissions and improve long-term survival.”

BCP-ALL was previously approved by the FDA in June 2024 for adult and pediatric patients one month or older with Philadelphia chromosome–negative CD19-positive BCP-ALL during the consolidation phase of multiphase therapy.

Reference

European Commission approves Blincyto® In Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia in the consolidation phase. Amgen. January 29, 2025. Accessed February 2, 2025. https://www.prnewswire.com/news-releases/european-commission-approves-blincyto-in-philadelphia-chromosome-negative-cd19-positive-b-cell-precursor-acute-lymphoblastic-leukemia-in-the-consolidation-phase-302363668.html