European regulators have approved an expanded approval for Amgen’s Blincyto monotherapy to include adult patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursors acute lymphoblastic leukaemia (ALL).
The approval was based on data from the Phase 2 BLAST study in frontline and relapsed/refractory ALL – the largest prospective trial for minimal residual disease (MRD)-positive ALL ever conducted.
Blincyto, a bispecific CD19-directed CD3 T cell engager (BiTE), is the first BiTE immunotherapy to receive regulatory approval globally.
“This approval represents a paradigm shift in the management of ALL in the European Union, making Blincyto the first and only treatment with marketing authorisation to include the presence of MRD,” said David M. Reese, Executive Vice President of R&D at Amgen.
Blincyto is the first immunotherapy from Amgen’s BiTE platform, an innovative approach that helps the body’s immune system target cancer cells.
BiTE antibody construct technology is an innovative treatment approach that helps the body’s immune system attack cancer cells without the removal of immune cells from the patient.