Posted by Michael Wonder on 23 Jan 2019
European Commission approves Blincyto (blinatumomab) in patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursor acute lymphoblastic leukaemia
22 January 2019 - Approval based on data from the Phase 2 BLAST study, the largest prospective trial in minimal residual disease-positive acute lymphoblastic leukaemia.
Amgen today announced that the European Commission has approved an expanded indication for Blincyto (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with minimal residual disease greater than or equal to 0.1%. The approval was based on data from the Phase 2 BLAST study in frontline and relapsed/refractory ALL, the largest prospective trial for MRD-positive ALL ever conducted. Blincyto, a bi-specific CD19-directed CD3 T cell engager (BiTE), is the first BiTE immunotherapy to receive regulatory approval globally.
