FDA approves sBLA for Blincyto (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).- Amgen

Amgen announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials. The approval is based on results from the Phase 1/II '205, an open-label, multicenter, single-arm trial, which evaluated the efficacy and safety of Blincyto in pediatric patients with relapsed or refractory B-cell precursor ALL.