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OCTOBER 13, 2016

Blincyto Approved for Pediatric Patients With B-Cell Precursor ALL

Drug: Blinatumomab (Blincyto, Amgen)

Status: Approved to treat pediatric patients with Philadelphia chromosome–negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

Significant Data:

  • The approval is based on results from the Phase I/II '205, an open-label, multicenter, single-arm trial, which evaluated the efficacy and safety of Blincyto in 93 patients with relapsed or refractory B-cell precursor ALL
  • Treatment in this study has been completed and subjects