Amgen's Bispecific Antibody Blincyto Receives FDA Approval for Consolidation Therapy in B-ALL with Over 80% Five-Year Survival Rate
Amgen
Developer of Treatment Drugs for Serious Diseases
▎WuXiEdited by Kant Content Team
Amgen announced today that the U.S. FDA has approved its bispecific antibody therapy Blincyto (blinatumomab) for the consolidation treatment of patients aged one month or older with CD19-positive, Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL), regardless of the measurable residual disease (MRD) status. This approval marks the third indication for Blincyto.
This approval is primarily based on the results of the Phase 3 clinical trial E1910. The trial investigated the effects of consolidation therapy following induction in newly diagnosed Philadelphia chromosome-negative B-ALL patients, with the aim of deepening remission to achieve durable responses.
The study results showed that, compared with chemotherapy alone, the addition of Blincyto to multi-phase consolidation chemotherapy demonstrated better overall survival (OS) benefits.In the Blincyto plus chemotherapy group (n=112), the 3-year overall survival rate was 84.8%, compared to 69% in the chemotherapy group (n=112), with an OS hazard ratio of 0.42.After a median follow-up of 4.5 years, the 5-year overall survival rate was 82.4% in the Blincyto plus chemotherapy group and 62.5% in the chemotherapy-alone group.
Blincyto is a bispecific T-cell engager (BiTE) developed by Amgen. One end binds to the CD19 antigen expressed on the surface of B cells, and the other end binds to the CD3 receptor on the surface of T cells.It can recruit T cells to the vicinity of cancer cells, promoting their killing of cancer cells. Blincyto has been approved by the FDA for the treatment of patients with relapsed/refractory B-cell ALL.
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References:
[1] FDA APPROVES BLINCYTO® (BLINATUMOMAB) IN CD19-POSITIVE PHILADELPHIA CHROMOSOME-NEGATIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) IN THE CONSOLIDATION PHASE. Retrieved June 14, 2024 from https://www.prnewswire.com/news-releases/fda-approves-blincyto-blinatumomab-in-cd19-positive-philadelphia-chromosome-negative-b-cell-precursor-acute-lymphoblastic-leukemia-b-all-in-the-consolidation-phase-302173376.html
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