NEW YORK – The US Food and Drug Administration on Friday approved Amgen's bispecific T-cell engager Blincyto (blinatumomab) as a consolidation treatment for adult and pediatric patients with CD19-positive, Philadelphia chromosome (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL).
The approval was based on results from the Phase III Study E1910 trial of Blincyto in adult patients with Ph-negative B-cell precursor ALL who had hematologic complete remission or complete remission with incomplete peripheral blood count recovery following induction and intensification chemotherapy. The study compared consolidation treatment with Blincyto monotherapy followed by chemotherapy against chemotherapy cycles alone. Patients in the study had a three-year overall survival rate of 84.8 percent on Blincyto versus 69 percent on just chemotherapy.
In the pediatric population, the approval was based on results from the Phase III Study 20120215, which included pediatric and young adult patients with Ph-negative B-cell precursor ALL who were 1 month old or older. Patients in this trial were randomized to receive either Blincyto or the IntReALLHR2010 HC3 intensive combination chemotherapy as the third consolidation cycle. The five-year overall survival rate was 78.4 percent on Blincyto compared to 41.4 percent on chemo. The five-year relapse-free survival rate was also improved on Blincyto, 61.1 percent, versus 27.6 percent on chemo.
"This approval redefines the standard of care for patients with B-ALL and provides them with a more effective treatment option than standard chemotherapy alone," Selina Luger, professor of hematology-oncology at the University of Pennsylvania's Perelman School of Medicine and Abramson Cancer Center and an investigator on the E1910 study, said in a statement.
Last year, the FDA granted full approval to Blincyto for the treatment of patients with minimal residual disease (MRD)-positive, CD19-positive B-cell precursor ALL who are in their first or second remission. The latest approval in B-ALL does not consider MRD status. The drug is also approved for relapsed or refractory CD19-positive B-ALL in adult and pediatric patients.