Posted by Michael Wonder on 03 Sep 2016
FDA approves Blincyto (blinatumomab) for use In paediatric patients with Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia
1 September 2016 - Amgen today announced that the U.S. FDA has approved the supplemental biologics license application for Blincyto (blinatumomab) to include new data supporting the treatment of paediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (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 1/2 '205, an open-label, multicenter, single-arm trial, which evaluated the efficacy and safety of Blincyto in paediatric patients with relapsed or refractory B-cell precursor ALL.
