Actionable news
0
All posts from Actionable news
Actionable news in AMGN: Amgen Inc.,

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 (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. 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.

"For researchers and physicians, overall survival is the primary goal...


More