The European Commission (EC) has approved Blincyto (blinatumomab) monotherapy as part of consolidation therapy for the treatment of adults with newly-diagnosed Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL).
This approval, based on the Phase III E1910 trial, allows earlier patient access to the Amgen (Nasdaq: AMGN) product, which is the first globally approved bispecific T-cell engager immuno-oncology therapy that targets CD19 surface antigens on B cells.
Jean-Charles Soria, senior vice president of global oncology development at the US biotech major, said: “This approval represents a significant advancement, offering patients the opportunity to receive Blincyto earlier in their treatment pathway, with the potential to improve outcomes.
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