The European Commission (EC) has granted approval for the use of Amgen ’s Blincyto as a monotherapy to treat adults with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL).
The indication covers patients who are in first or second complete remission and have a minimal residual disease (MRD) greater than or equal to 0.1%.
Blincyto is a bispecific CD19-directed CD3 T cell engager based on Amgen ’s BiTE antibody construct technology that aid the body’s immune system to attack cancer cells.
The drug is the first BiTE immunotherapy, and the company is currently developing multiple other candidates targeting hematologic and solid tumours.
Amgen Research and Development executive vice-president David Reese said: “This approval represents a paradigm shift in the management of ALL in the European Union, making Blincyto the first and only treatment with marketing authorisation to include the presence of MRD.
“We are pleased that the European Commission has seen the value Blincyto can bring to people living with ALL and are proud to continue to deliver on our commitment to the pursuit of breakthroughs that can transform the lives of cancer patients.”
The approval comes after review of results from the Phase II BLAST clinical trial performed in adults with MRD-positive B-cell precursor ALL in complete hematologic remission following three or more cycles of chemotherapy.
During the open-label, multi-centre, single-arm trial, the drug was evaluated for its efficacy, safety and tolerability.
Results showed that the drug triggered a complete MRD response, or no detectable MRD, in 78% of patients who received one treatment cycle.
Safety profile in MRD-positive patients was observed to be consistent with the known profile in relapsed or refractory B-cell precursor ALL.
Currently, Blincyto holds approvals in a total of 57 countries, including all member countries the EU and EEA, the US, Canada, Japan and Australia.
The drug secured the European authorisation for Ph- relapsed or refractory B-precursor ALL last year.