NEW YORK – The European Commission on Wednesday approved Amgen's bispecific T-cell engager Blincyto (blinatumomab) as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome (Ph)-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).
The approval allows these patients to receive Blincyto earlier in their treatment pathway, after receiving their initial induction therapy. In Europe, Blincyto was previously approved for pediatric and adult patients with Ph-negative CD19-positive B-cell precursor ALL who had relapsed or refractory disease or who were minimal residual disease (MRD)-positive in their first or second complete remission. Blincyto was also previously approved as part of consolidation therapy for pediatric patients with high-risk Ph-negative CD19-positive B-cell precursor ALL. The drug can also be given to Ph-positive CD19-positive B-cell precursor ALL patients who have received at least two prior lines of treatment and have no other options.
The new EC approval was based on results from the Phase III E1910 clinical trial, in which researchers evaluated Blincyto added to multiphase consolidation chemotherapy compared to chemo alone. In the trial, with a median follow-up of 4.5 years, the five-year overall survival rate was 82.4 percent in the Blincyto plus chemotherapy arm and 62.5 percent in the chemotherapy arm. The E1910 trial was led by the ECOG-ACRIN Cancer Research Group and conducted independently from the pharma industry.
"While there has been some treatment progress, many patients with newly diagnosed Philadelphia chromosome-negative B-ALL remain at high risk of relapse," Robin Foà, emeritus professor of hematology at Sapienza University of Rome, said in a statement. "The E1910 study results highlight that Blincyto has the potential to advance frontline consolidation treatment, including [in] patients who are minimal residual disease-negative, offering a crucial new option to achieve deeper remissions and improve long-term survival."
Last year, the US Food and Drug Administration similarly approved Blincyto for consolidation treatment. However, the FDA approval included both adult and pediatric patients with newly diagnosed Ph-negative CD19-positive B-cell precursor ALL.