Amgen announced that the Food and Drug Administration (FDA) has converted the accelerated approval for Blincyto (blinatumomab) to a full approval for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in children and adults.
The supplemental Biologics License Application (sBLA) has been approved to include overall survival (OS) data from the Phase 3 TOWER study and data from the Phase 2 ALCANTARA study. The full approval now expands the use of Blincyto to treat relapsed or refractory B-cell precursor ALL in children and adults.
The TOWER study (n=405) demonstrated a superior improvement in median OS with Blincyto vs. standard of care (SOC) chemotherapy (7.7 months vs. 4 months, hazard ratio [HR] 0.71; P=0.012). Data from the ALCANTARA study (n=45) further supported the efficacy of Blincyto in adults with Ph+ relapsed or refractory B-cell precursor ALL based on the complete remission rate, duration of complete remission, and proportion of patients with an MRD-negative complete remission with partial hematologic recovery within two cycles.
Blincyto, a CD19-directed CD3 bispecific T-cell engager (BiTE) antibody, is the first single-agent immunotherapy to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL. It was previously granted Breakthrough Therapy and Priority Review designations.
Blincyto is available as 35mcg strength lyophilized powder for IV infusion in single-use vials.
For more information call (800) 772-6436 or visit Blincyto.com.