The U.S. Food and Drug Administration (FDA) granted accelerated approval to blinatumomab (Blincyto) for the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1
Approval of this supplemental Biologics License Application is based on findings from Study ‘205, an open-label, multicenter, single-arm trial, which assessed the efficacy and safety of blinatumomab among 93 children with relapsed or refractory B-cell precursor ALL.
In May 2016, it was reported that the trial met its phase 2 primary end point of complete remission within the first 2 cycles of immunotherapy.
Continued approval may be contingent upon verification of clinical benefit in additional studies.
The most common grade 3 or worse treatment-related adverse events among those who received the recommended dose were anemia, neutropenia, febrile neutropenia, thrombocytopenia, and hypokalemia.
Blinatumomab is a bispecific CD19-directed CD3 T cell engager (BiTE®) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. It is also approved for this indication in adult patients.
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Clinicians should be aware that blinatumomab may cause life-threatening or fatal cytokine release syndrome, and neurological toxicities that may be severe, life-threatening, or fatal.
- FDA approves Blincyto (blinatumomab) for use in pediatric patients with philadelphia chromosome-negative relapsed or refractory b-cell precursor acute lymphoblastic leukemia [press release]. Amgen website. http://www.amgen.com/media/news-releases/2016/09/fda-approves-blincyto-blinatumomab-for-use-in-pediatric-patients-with-philadelphia-chromosomenegative-relapsed-or-refractory-bcell-precursor-acute-lymphoblastic-leukemia. Updated September 1, 2016. Accessed September 1, 2016.