Blinatumomab injection approved in China for pediatric relapsed or refractory CD19+ B-cell precursor acute lymphoblastic leukemia

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.

NMPA

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).

U.S. Food and Drug Administration

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

• R/R CD19⁺ B-ALL
• CD19⁺ B-ALL in first or second complete remission with minimal residual disease ≥0.1%

European Union

In January 2019, Blinatumomab was approved in the European Union (EU) as a monotherapy to treat

• Adults with Ph⁻ CD19⁺ R/R B-ALL who failed treatment with ≥2 tyrosine kinase inhibitors and have no alternate option.
• Adults with Ph⁻ CD19⁺ B-ALL in first or second complete remission with minimal residual disease ≥0.1%.
• Pediatric patients ≥1 year of age with Ph⁻ CD19⁺ R/R B-ALL who had received ≥2 prior therapies or are in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.
• Pediatric patients ≥1 year of age with high-risk first relapsed Ph⁻ CD19⁺ R/R B-ALL as part of consolidation therapy.