Posted by Michael Wonder on 12 Jul 2017
FDA grants full approval for Blincyto (blinatumomab) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukaemia in adults and children
11 July 2017 - Data from the phase 3 TOWER study support conversion from accelerated to full approval.
Amgen today announced that the U.S. FDA has approved the supplemental biologics license application for Blincyto (blinatumomab) to include overall survival data from the phase 3 TOWER study. The approval converts Blinctyo's accelerated approval to a full approval.
The sBLA approval also included data from the Phase 2 ALCANTARA study supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). The approval expands the indication of Blincyto for the treatment of relapsed or refractory B-cell precursor ALL in adults and children.
