Amgen Receives CHMP Positive Opinion to Expand Use of Blincyto

Amgen announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 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 2 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.
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 continued acknowledgment of MRD status as an approvable endpoint is an important step in the larger paradigm shift of ALL management as early intervention within the ALL treatment continuum has been shown to be an important step in eliminating dangerous detectable disease," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We appreciate the efforts undertaken by the ALL community to work with regulators and other decision makers on the role of MRD in recurrence of disease and look forward to a final decision by the European Commission."

The CHMP opinion is based on data from the Phase 2 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.

The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions based on the decision of the EC. The CHMP previously adopted a negative opinion in July 2018 but revised the opinion following a re-examination request by Amgen.

In March 2018, the U.S. Food and Drug Administration (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. Blincyto is the first immunotherapy from Amgen's BiTE platform, an innovative approach that helps the body's immune system target cancer cells.

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