Posted by Michael Wonder on 30 Aug 2018
European Commission approves Blincyto (blinatumomab) for use in paediatric patients with Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
29 August 2018 - Approval Based on Data From the Phase 1/2 '205 Study.
Amgen today announced that the European Commission has approved an expanded indication for Blincyto (blinatumomab) as monotherapy for the treatment of paediatric patients aged one year or older with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL), which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation.
The approval is based on results from the Phase 1/2 '205 study, 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.
