FDA Approves Blinatumomab for Pediatric B-cell Precursor ALL
The FDA granted accelerated approval to blinatumomab (Blincyto) for the treatment of pediatric patients with acute lymphoblastic leukemia.
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.