Phase III data show Blincyto's survival benefit

Amgen Inc. (NASDAQ:AMGN) said Blincyto blinatumomab led to overall survival (OS) of 7.7 months vs. 4 months for standard of care (HR=0.71; p=0.012) in the Phase III TOWER study to treat Philadelphia chromosome-negative relapsed or refractory precursor B cell acute lymphoblastic leukemia (ALL).

Blincyto has accelerated approval from FDA in the indication, and conditional approval in the EU. Amgen plans to use the TOWER data to pursue full approval of the bispecific T cell engager (BiTE) that binds to CD19 and CD3. ...