FDA Grants Full Approval for BLINCYTO ® (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children

BLINCYTO is the First-and-Only Bispecific T Cell Engager (BiTE®) Immunotherapy to Demonstrate Superior Overall Survival Versus Standard of Care Chemotherapy Data From the Phase 3 TOWER Study Support Conversion From Accelerated to Full Approval Indication Expansion Underscores Need for Effective Treatment Options THOUSAND OAKS, Calif., July 11, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include overall survival (OS) data from the Phase 3 TOWER study. The approval converts BLINCYTO's accelerated approval to a full approval. T...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news