Amgen’s Blincyto (blinatumomab) has been approved by the European Commission (EC) to treat certain acute lymphoblastic leukaemia (ALL) patients earlier in their treatment journey.
Blincyto monotherapy is now approved to treat adults with newly diagnosed CD19-positive Philadelphia chromosome-negative B-cell precursor ALL in the consolidation phase, a phase of frontline treatment for ALL which is aimed at killing any remaining leukaemia cells.
Affecting an estimated 1.28 per 100,000 people in Europe, ALL is a fast-growing type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body. B-ALL is the most common form of the disease, accounting for approximately 75% of cases in adults.
Despite the majority of patients being in remission after induction treatment, there is need for targeted treatments that reduce the number of remaining leukaemia cells that could cause a subsequent relapse.
Administered as an intravenous infusion, Blincyto is a bispecific T-cell engager immuno-oncology therapy designed to target CD19 surface antigens on B cells and is already approved in the EU for certain B-ALL patients.
The EC’s latest decision on the drug was supported by positive results from the late-stage E1910 trial led by the ECOG-ACRIN Cancer Research Group, in which Blincyto added to multiphase consolidation chemotherapy showed superior overall survival (OS) against chemotherapy alone.
At a median follow-up of 4.5 years, the five-year OS was 82.4% in the Blincyto/chemotherapy cohort and 62.5% in the chemotherapy arm.
Jean-Charles Soria, senior vice president of global oncology development at Amgen, said: “This approval represents a significant advancement, offering patients the opportunity to receive Blincyto earlier in their treatment pathway, with the potential to improve outcomes.
“The E1910 data that served as the basis of this approval adds to the growing body of evidence of the meaningful survival impact of Blincyto.”
The authorisation comes just over a month after Blincyto was approved by the Medicines and Healthcare products Regulatory Agency to treat adults with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL in the consolidation phase. The US Food and Drug Administration also approved of the drug in the same indication in June.