FDA Grants Priority Review For Amgen's BLINCYTO ® (blinatumomab) Supplemental Biologics License Application

Application Includes Overall Survival Data From Phase 3 TOWER Study to Support Conversion From Accelerated Approval to Full Approval Acceptance Reinforces Significant Need for Innovative Treatment Options for Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia BLINCYTO is the First-and-Only Approved Bispecific CD19-Directed CD3 T Cell Engager (BiTE®) Immunotherapy THOUSAND OAKS, Calif., March 29, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include overall survival (OS) data from the Phase 3 ...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news