CHMP recommends expanding approval of Blincyto in acute lymphoblastic leukemia.- Amgen.
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion to expand the current indication for Blincyto (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative 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 percent.
The application included 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, is the first BiTE immunotherapy to receive regulatory approval globally.
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