Research & Development
BeiGene Receives China Approval of Blincyto for Injection for Pediatric Patients with Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
5 May 2022 - - The China National Medical Products Administration has granted conditional approval of Blincyto (blinatumomab) for injection for the treatment of pediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia, Chinese biotechnology company BeiGene (NASDAQ: BGNE) (HKEX: 06160) (SSE: 688235) said.

The NMPA granted conditional approval for adult patients in this indication in December 2020.

Developed by Amgen and licensed to BeiGene in China under a strategic collaboration commenced in 2020, this is the second approval for Blincyto in China. The pediatric Supplemental Biologic License Application was submitted by BeiGene.

Blincyto for injection for the treatment of adult patients with R/R CD19-positive B-cell precursor ALL was approved conditionally based on ex-China data and interim analysis results of the Phase 3 clinical trial of adult patients in China (NCT03476239).

This conditional approval in pediatric patients with the above indication was granted based on ex-China research data and Chinese adult data. The full approval in this indication will depend on the results of a post-marketing study in China.

Acute lymphoblastic leukemia, also known as acute lymphocytic leukemia, is a rapidly progressing cancer of the blood and bone marrow that occurs in both adults and children.

ALL accounts for approximately 20% of all adult leukemia, and in China there were an estimated 82,607 new cases of leukemia in 2018.

In children, the relapse rate of ALL is nearly 10%, while in adults the relapse rate is closer to 50%.

Blincyto is a BiTE (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells.

BiTE molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells.

By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis).

BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.

Blincyto was granted breakthrough therapy and priority review designations by the US Food and Drug Administration and is approved in the US for several indications.

Blincyto is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
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