Amgen Submits Supplemental Biologics License Application For BLINCYTO® (Blinatumomab) In Relapsed Or

Amgen press release ---- Amgen (NASDAQ: AMGN) announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for BLINCYTO® (blinatumomab) to include overall survival (OS) data from the Phase 3 TOWER study, supporting the conversion of BLINCYTO's accelerated approval to full approval. The sBLA also includes new data supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The application aims to broaden BLINCYTO's indication for the treatment of patients with relapsed or refractory B-cell precursor ALL. BLINCYTO was previously granted breakthrough therapy designation and accelerated approval in December 2014. It is also the first FDA-approved bispecific CD19-directed CD3 T cell engager (BITE®) antibody, and the first single-agent immunotherapy to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL. To learn more click on the picture below to read the release.