FDA grants full supplemental approval for Blincyto to treat minimal residual disease B-cell precursor acute lymphoblastic leukemia.- Amgen
Amgen announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, based on additional data from two Phase III studies that were submitted.
The approval converts Blinycto's accelerated approval to a full approval.
"In a Phase II study, roughly 80% of adult patients treated with blinatumomab experienced a complete MRD ( minimal residual disease) response," said principal investigator Elias Jabbour, M.D., Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston. "The FDA's decision to grant a full approval for blinatumomab further validates the use of this therapy to treat adults and children with B-cell precursor ALL with MRD present following a remission, which is a strong predictor of relapse in this patient population."
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