FDA approves blinatumomab for consolidation in Ph-negative B-cell precursor ALL
The agency's June 14, 2024 approval covers Amgen's Blincyto for patients as young as one month with CD19-positive, Philadelphia chromosome-negative disease.
The FDA cleared a new use for blinatumomab, sold by Amgen Inc. under the brand name Blincyto, on June 14, 2024. The approval covers adult and pediatric patients one month and older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia, specifically for use in the consolidation phase of multiphase chemotherapy.1
The approval expands the drug's role in treating this subtype of acute lymphoblastic leukemia by authorizing its use during the consolidation stage of treatment, which follows initial induction chemotherapy. No additional details on trial data, dosing specifics, or further regulatory milestones were included in the FDA's announcement.
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