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# Amgen’s Blincyto Gets Expanded Leukemia Use
- URL: https://www.fdaweb.com/amgens-blincyto-gets-expanded-leukemia-use/
- Published: 2024-06-14T12:00:00.000Z
- Updated: 2026-09-14T14:33:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157187

FDA has approved an expanded use for 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 in the consolidation phase, regardless of measurable residual disease status. The company says the approval is based on data from the Phase 3 E1910 clinical trial demonstrating that Blincyto added to multiphase consolidation chemotherapy showed “superior” overall survival (OS) versus chemotherapy alone.

The three-year OS was 84.8% in the Blincyto plus chemotherapy arm (n=112) and 69% in the chemotherapy arm (n=112), Amgen says, and the five-year OS was 82.4% in the combination arm and 62.5% in the chemotherapy arm.

Blincyto is described as a BiTE immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE molecules fight cancer by helping the body’s immune system detect and target malignant cells by engaging T cells against cancer cells. “By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis),” Amgen says.