Blinatumomab Receives Full FDA Approval for MRD-Positive B-Cell Precursor ALL

The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for blinatumomab as a therapy for adults and children with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) who are in their first or second complete remission (CR) with measurable residual disease (MRD) of at least 0.1%, according to a news release from Amgen.

This approval converts the accelerated approval of blinatumomab—a bispecific T-cell engager that targets CD19 surface antigens on B cells—to a full approval. The approval is based on additional data from two studies that were submitted.

“In a phase II study, roughly 80% of adult patients treated with blinatumomab experienced a complete MRD response,” principal investigator Elias Jabbour, MD, of the University of Texas MD Anderson Cancer Center, said in the news release. “The FDA’s decision to grant a full approval for blinatumomab further validates the use of this therapy to treat adults and children with B-cell precursor ALL with MRD present following a remission, which is a strong predictor of relapse in this patient population.”

The US FDA previously granted breakthrough therapy and priority review designations to blinatumomab. In addition to its approval for patients with CD19-positive B-ALL who are in their first or second CR with MRD of at least 0.1%, blinatumomab is also approved in the United States for the treatment of relapsed or refractory CD19-positive B-ALL in adults and children.

Source: Amgen, June 2023