Sept. 1, 2016
Amgen has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may depend upon verification of clinical benefits in subsequent trials.
The approval is based on results from the Phase 1/2 ‘205, an open-label, single-arm, multicenter trial, which evaluated the safety and efficacy of BLINCYTO in pediatric patients with relapsed or refractory B-cell precursor ALL.
BLINCYTO was granted conditional marketing authorization in the European Union in November, 2015 for the treatment of adults with Ph- relapsed or refractory B-cell precursor ALL.BLINCYTO® (blinatumomab) is Approved by FDA for Use in Pediatric Patients with Philadelphia Chromosome-Negative Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemialast edit: 2016-09-14T18:17:51+00:00da