Expanded use of Blincyto approved in Europe

The European Commission (EC) 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 leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

As a result, Amgen’s (Nasdaq: AMGN) Blincyto becomes the first and only therapy for minimal residual disease approved in the European Union, the US biotech major noted.

The approval was based on data from the Phase II BLAST study in frontline and relapsed/refractory ALL, the largest prospective trial for 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.