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# Amgen Seeks Expanded Blincyto Indication
- URL: https://www.fdaweb.com/amgen-seeks-expanded-blincyto-indication/
- Published: 2024-02-07T12:00:00.000Z
- Updated: 2026-09-14T14:22:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156316

FDA has accepted for priority review an Amgen supplemental BLA for Blincyto (blinatumomab) for treating early-stage, CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). Currently, the drug is approved for the B-ALL patient population after the first or second complete remission with minimal residual disease.

The submission is based in part on the Phase 3 E1910 study conducted by the National Cancer Institute, the Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network Cancer Research Group. The agency has set a user fee review action target date of 6/21.

Blincyto is described by Amgen as a BiTE (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE molecules help 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),” the company says.