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ALL Treatment Receives FDA Approval

September 12, 2023

October 2023

Blinatumomab received U.S. Food and Drug Administration (FDA) approval for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with measurable residual disease (MRD) greater than or equal to 0.1%. The drug previously received accelerated approval from the FDA but was granted full approval based on data from two phase III studies.

The treatment is a bispecific T-cell engager immuno-oncology therapy that works by targeting CD19 surface antigens on B cells. It is the first FDA-approved CD19-directed CD3 bispecific T-cell engager immunotherapy.

Blinatumomab also received breakthrough therapy and priority review designations from the FDA in earlier development stages. Additionally, the European Union has approved blinatumomab as a monotherapy for adults with Philadelphia chromosome-negative CD19-positive relapsed or refractory (R/R) B-cell precursor ALL; adults with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL in first or second complete remission with MRD greater than or equal to 0.1%; and pediatric patients aged 1 year or older with Philadelphia chromosome-negative CD19-positive B-precursor ALL that is R/R after receiving at least two therapies or in relapse after receiving allogeneic hematopoietic cell transplantation.

“In a phase II study, roughly 80% of adult patients treated with blinatumomab experienced a complete MRD response,” said principal investigator Elias Jabbour, MD, of the University of Texas MD Anderson Cancer Center in Houston. “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.”

Source: Amgen, June 21, 2023.

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