Posted by Michael Wonder on 20 Jun 2018
Amgen receives European Commission approval to add overall survival data to Blincyto (blinatumomab) label
19 June 2018 - Blinctyo is the first-and-only approved bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy.
Amgen today announced that the European Commission has granted a full marketing authorisation for Blincyto (blinatumomab) based on the overall survival (OS) data from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukaemia.
In the TOWER study, Blincyto demonstrated a superior improvement in median OS over standard of care chemotherapy.
