European Commission approves Blincyto to to include (Ph-) CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD).- Amgen

Amgen announced that 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 percent.

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.

Blincyto is now approved in 57 countries, including all member countries in the EU and EEA, Canada , Japan and Australia .

MRD refers to the presence of cancer cells that remain detectable, despite a patient having achieved complete remission by conventional assessment. MRD is only measurable through the use of highly sensitive testing methods that detect cancer cells in the bone marrow with a sensitivity of at least one cancer cell in 10,000 cells - versus about one in 20 with a conventional microscope-based evaluation..

The EC approval is based on data from the Phase II BLAST study, which found that Blincyto induced a complete MRD response, or no detectable MRD, in 78 percent of patients within one treatment cycle. Safety results among MRD-positive patients were consistent with the known safety profile of Blincyto in relapsed or refractory B-cell precursor ALL.

Comment: In March 2018 , the FDA approved Blincyto for the treatment of adults and children with B-cell precursor ALL in first or second complete remission with MRD greater than or equal to 0.1 percent.