Posted by Michael Wonder on 30 Mar 2017
FDA grants priority review for Amgen's Blincyto (blinatumomab) supplemental biologics license application
29 March 2017 - Application includes overall survival data from phase 3 TOWER study to support conversion from accelerated approval to full approval.
Amgen today announced that the U.S. FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) to include overall survival data from the Phase 3 TOWER study. 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 expand Blincyto's indication for the treatment of all patients with relapsed or refractory B-cell precursor ALL and supports the conversion of Blincyto's accelerated approval to full approval.
Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions. The Prescription Drug User Fee Act target action date is 14 August 2017.
