FDA approves Blincyto (blinatumomab) for treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase.- Amgen

"B-ALL is an aggressive blood cancer with enduring high unmet need. Blincyto has helped thousands of patients with B-ALL over the last 10 years. Today's approval in the frontline consolidation phase, regardless of MRD status, allows us to reach more patients than ever with this transformative, first-in-class Bispecific T-cell Engager (BiTE) therapy," said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen.

The approval marks the third indication for Blincyto and is based primarily on the Phase III E1910 clinical trial led by ECOG-ACRIN Cancer Research Group that studied patients with newly diagnosed Philadelphia chromosome-negative B-ALL receiving postinduction consolidation treatment, which aims to deepen remission to achieve durable responses. Study results demonstrated that Blincyto added to multiphase consolidation chemotherapy showed superior overall survival (OS) versus chemotherapy alone. The 3-year OS was 84.8% in the Blincyto plus chemotherapy arm (n=112) and 69% in the chemotherapy arm (n=112), with the hazard ratio for OS of 0.42. With a median follow-up of 4.5 years, the 5-year OS was 82.4% in the Blincyto plus chemotherapy arm and 62.5% in the chemotherapy arm.