Blinatumomab Receives FDA Approval in B-Cell ALL

The US Food and Drug Administration (FDA) has approved blinatumomab, a CD19-directed monoclonal antibody, for the treatment of CD19-positive, Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL), according to a release from Amgen.

Blinatumomab is now indicated for use in adult and pediatric patients aged one month or older with B-ALL in the consolidation phase of treatment, regardless of measurable residual disease (MRD) status.

The approval was predicated primarily on data from the phase III E1910 trial that showed blinatumomab added to multiphase consolidation chemotherapy achieved superior overall survival (OS) compared with chemotherapy alone.

Blinatumomab Treatment for B-Cell ALL

In the trial, the three-year OS rate was 84.8% with blinatumomab versus 69% with chemotherapy alone (hazard ratio, 0.42). Additionally, at a median follow-up of 4.5 years, the rate of five-year OS was 82.4% in the blinatumomab group versus 62.5% in the chemotherapy-only group.

“In the E1910 study, blinatumomab reduced risk of death and showed a remarkable improvement in [OS],” said Selina Luger, MD, an investigator on E1910 from the University of Pennsylvania Perelman School of Medicine and Abramson Cancer Center. “This approval redefines the standard of care for patients with B-ALL and provides them with a more effective treatment option than standard chemotherapy alone.”

This is the third FDA-approved indication for blinatumomab, adding to previous approvals for adult and pediatric patients one month or older with CD19-positive B-ALL in first or second complete remission with MRD greater than or equal to 0.1% or with relapsed or refractory CD19-positive B-ALL.

Related: What Is the Benefit of Blinatumomab in MRD-Positive B-Cell ALL?