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# Amgen’s Blincyto Gets Expanded Approval
- URL: https://www.fdaweb.com/amgens-blincyto-gets-expanded-approval/
- Published: 2024-08-27T12:00:00.000Z
- Updated: 2026-09-14T14:39:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157663

FDA has approved Amgen’s Blincyto (blinatumomab) for treating adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status.

Approval is based on data from the Phase 3 E1910 clinical trial that studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, according to the company. “Study results demonstrated that Blincyto added to multiphase consolidation chemotherapy showed superior overall survival (OS) versus chemotherapy alone,” it says. “The three-year OS was 84.8% in the BLINCYTO plus chemotherapy arm (n=112) and 69% in the chemotherapy arm (n=112).”

The company notes that the risk of B-ALL recurrence after the initial treatment phase is high, which makes the approval for patients “noteworthy.”

Previously, Blincyto was approved for CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1% in adults and pediatric patients one month or older. It is also approved for relapsed or refractory CD19-positive B-ALL in adults and pediatric patients one month or older.