Amgen announced that it has submitted to the Food and Drug Administration (FDA) a supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab), to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The sBLA submission is supported by data from Study ‘205, a single-arm, multicenter, dose-finding Phase 1/2 efficacy trial in patients <18 years of age with Ph- B-cell precursor ALL that was refractory, had relapsed at least twice or relapsed after an alloHSCT.
Results from the study found that treatment with Blincyto induced complete remission in a clinically meaningful number of pediatric patients. Serious adverse events reported in the pediatric population are consistent with Blincyto’s known safety profile. The treatment period has been completed and patients are being monitored for long-term efficacy. Detailed findings will be submitted for publication.
Blincyto is the first and only FDA-approved bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy. It is currently available under an accelerated approval for the treatment of Ph- relapsed or refractory B-cell precursor ALL.
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