Amgen has announced that the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) to include overall survival (OS) data has been accepted for priority review by the Food and Drug Administration (FDA).

The sBLA also includes data supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). 

Blincyto is a CD19-directed CD3 bispecific T cell engager (BiTE) antibody, and the first single-agent immunotherapy approved to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL. 

The sBLA application is based on the results from two separate Blincyto trials; the confirmatory Phase 3, active-controlled, open-label trial, TOWER, which examined Blincyto vs. standard-of-care (SOC) chemotherapy in 405 patients with Ph- relapsed or refractory B-cell precursor ALL; and the ALCANTARA trial, a Phase 2 single-arm, multicenter, open-label study of 45 patients with Ph+ B-cell precursor ALL. 

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The results from the TOWER trial demonstrated that Blincyto had a statistically significant improvement in OS vs. chemotherapy when used early (in first salvage; 11.1 months versus 5.3 months). The ALCANTARA primary endpoint was complete remission or complete remission with partial hematologic recovery during the first two cycles of treatment. The Blincyto group’s results were comparable to those in Phase 2 studies involving patients with Ph- relapsed or refractory B-cell precursor ALL—giving support to future Phase 3 studies.

“Blincyto is the first-and-only approved bispecific immunotherapy with superior OS results versus standard of care chemotherapy, […] we look forward to making this important potential new option available to patients with all forms of relapsed or refractory B-cell ALL,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. 

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