Amgen announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) 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). BLINCYTO, the first-and-only FDA-approved bispecific CD19-directed CD3 T cell engager (BiTE®) immunotherapy, is currently available under an accelerated approval in the U.S. for the treatment of Ph- relapsed or refractory B-cell precursor ALL, a rare and rapidly progressing cancer of the blood and bone marrow impacting both adults and children.
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