Amgen’s Blincyto Wins FDA Approval for Expanded Leukemia Use

1. Expanded FDA Approval: Blincyto (blinatumomab) received accelerated approval from the FDA to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD).
2. MRD-Positive ALL: The approval targets patients with MRD-positive ALL, which means they have an increased risk of relapse despite achieving remission after initial treatment.
3. Bispecific Antibody: Blincyto is a bispecific antibody that attaches to CD19 protein on leukemia cells and CD3 protein on immune system cells, enabling the immune cells to attack the leukemia cells more effectively.
4. Clinical Trial Results: A single-arm clinical trial showed that Blincyto helped patients achieve undetectable MRD, which may improve long-term survival outcomes.
5. Priority Review and Orphan Drug Designation: The FDA granted Priority Review and Orphan Drug designation to Blincyto, recognizing its potential to address an unmet medical need for rare diseases.
6. Previous Approvals: Blincyto was initially approved in December 2014 for relapsed or refractory B-cell precursor ALL and received full approval in July 2017.
7. Potential for Further Expansion: Research is ongoing to explore Blincyto's use in consolidation therapy for MRD-negative ALL patients, which could lead to further expanded indications.