A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)

Trial Profile

A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)

Discontinued
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2017

At a glance

  • Drugs Blinatumomab (Primary) ; Antineoplastics
  • Indications Acute lymphoblastic leukaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms TOWER
  • Sponsors Amgen
  • Most Recent Events

    • 11 Jul 2017 According to an Amgen media release, the approval expands the indication of BLINCYTO for the treatment of relapsed or refractory B-cell precursor ALL in adults and children.
    • 11 Jul 2017 According to an Amgen media release, the US FDA has approved the 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).
    • 25 Jun 2017 Safety and tolerability results presented at the 22nd Congress of the European Haematology Association
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