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On May 4, 2022, it was announced that blinatumomab for injection received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of pediatric patients with relapsed or refractory (R/R) CD19+ B-cell precursor acute lymphoblastic leukemia (B-ALL).
Blinatumomab is an anti-CD19 bispecific T-cell engager; other indications and prior approvals are outlined below.
In December 2020, blinatumomab received conditional approval from the NMPA for the treatment of R/R CD19+ B-ALL in adult patients, a decision based on an interim analysis of a phase III, multicenter clinical trial (NCT03476239).
In March 2018, following breakthrough therapy and priority review designations, blinatumomab was approved by the U.S. Food and Drug Administration (FDA) to treat adults and children with
In January 2019, Blinatumomab was approved in the European Union (EU) as a monotherapy to treat
AALL1331: blinatumomab improves outcomes for some low-risk pediatric and AYA patients with first relapse of B-ALL
Survival remains poor for first relapse of B-cell acute lymphoblastic leukemia (B-ALL) in children, adolescent, and young adult (AYA)...
Young adult and pediatric ALL: Current induction regimens and prognostic factors
In a review published in Expert Review of Hematology, Saveria Capria and colleagues discuss the currently available induction treatments for children and adolescents...
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