EU marketing approval for Amgen’s Blincyto

Blincyto approved in Europe
Courtesy of Amgen

Amgen has secured a full marketing authorisation in Europe for Blincyto, the first-and-only approved bispecific CD19-directed CD3 T cell engager (BiTE®) immunotherapy.

The European Commission approval was based on the overall survival data from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

Blincyto is the first-and-only bispecific CD19-directed CD3 T cell engager (BiTE®) immunotherapy construct approved globally.

It is also the first bispecific immunotherapy from Amgen’s BiTE® platform, an innovative approach that helps the body’s immune system target cancer cells.