> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves Amgen sBLA for Blincyto
- URL: https://www.fdaweb.com/fda-approves-amgen-sbla-for-blincyto/
- Published: 2017-07-14T12:00:00.000Z
- Updated: 2026-09-14T22:34:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139140

FDA has approved an Amgen supplemental BLA 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 relapsed or refractory B-cell precursor acute lymphoblastic leukemia. (ALL). Additionally, the approval expands the therapy’s indication for treating relapsed or refractory B-cell precursor ALL in adults and children.