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Amgen Says FDA Approves SBLA For BLINCYTO To Include Overall Survival

Amgen (AMGN) said that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for BLINCYTO (blinatumomab) to include overall survival data from the Phase 3 TOWER study. The approval converts BLINCYTO's accelerated approval to a full approval.

The sBLA approval also included data from the Phase 2 ALCANTARA study supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The approval expands the indication of BLINCYTO for the treatment of relapsed or refractory B-cell precursor ALL in adults and children.

BLINCYTO, the first single-agent immunotherapy to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL, was previously granted breakthrough therapy designation and accelerated approval. It is also the first-and-only FDA-approved CD19-directed CD3 bispecific T cell engager (BiTE) immunotherapy, and the first bispecific antibody construct from Amgen's BiTE platform.

by RTTNews Staff Writer

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