Amgen’s Blincyto secures expanded indication in Europe for acute lymphoblastic leukaemia
pharmafile | January 23, 2019 | News story | Research and Development, Sales and Marketing | Ammgen, Cancer, Europe, European Commission, blincyto, leukaemia, pharma
The European Commission has chosen to expand the authorised indication for Amgen’s Blincyto (blinatumomab) in the region, it has emerged, approving it for the treatment of Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukaemia (ALL).
Specifically, the approval concerns patients in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, with MRD referring to the presence of detectable cancer cells following the achievement of complete remission.
The decision was made on the back of Phase 2 data which demonstrated that Blincyto induced a complete MRD response in 78% of patients within one cycle of treatment, while safety data was in line with previous studies.
“Survival rates for patients that achieve MRD-negativity are significantly higher than those for patients that remain MRD-positive, underscoring the critical importance of early testing for and eliminating residual disease in patients with ALL,” said Dr Nicola Gökbuget, Principal Investigator for the BLAST study and head of the German Multicenter Study Group for Adult ALL. “Data from the BLAST study demonstrated that Blincyto is effective in eliminating detectable residual disease and showed the potential to improve relapse-free survival in this patient population. Today’s approval provides physicians across Europe with a much-needed treatment option that can potentially help prevent a relapse, which is associated with a very unfortunate prognosis.”
Dr David M. Reese, Executive Vice President of Research and Development at Amgen, added: “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.”
Matt Fellows
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