FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
• Conversion From Accelerated to Full Approval
• Reinforces Blincyto as Standard of Care for Patients With Minimal Residual Disease at Baseline After Remission
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, based on additional data from two Phase 3 studies that were submitted. The approval converts Blincyto’s accelerated approval to a full approval.
Amgen continues to advance a robust development program for Blincyto, including studies aimed at treating patients with MRD-negative B-ALL, trials designed to minimize chemotherapy, and the clinical investigation of a subcutaneous formulation, all intended to help address remaining unmet needs for patients.
