Posted by Michael Wonder on 15 Feb 2017
Amgen submits supplemental biologics license application for Blincyto (blinatumomab) in relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
14 February 2017 - Application includes overall survival data from phase 3 TOWER study to support conversion from accelerated approval to full approval.
Amgen today announced the submission of a supplemental biologics license application to the U.S. FDA for Blincyto (blinatumomab) to include overall survival data from the Phase 3 TOWER study, supporting the conversion of Blincyto''s accelerated approval to full approval.
The application also includes new data supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). The application aims to broaden Blincyto's indication for the treatment of patients with relapsed or refractory B-cell precursor ALL.
