The FDA has approved the supplemental biologics license application for blinatumomab (Blincyto, Amgen) to include new data 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 be contingent upon verification of clinical benefit in subsequent trials.
The approval is based on results from the phase 1/2 ‘205 study, an open-label, multicenter, single-arm trial, which evaluated the efficacy and safety of blinatumomab in 93 pediatric patients with relapsed or refractory B-cell precursor ALL. Treatment in this study has been completed and subjects are being monitored for long-term efficacy.
Blinatumomab is a bispecific CD19-directed CD3 T cell engager (BiTE) antibody construct that binds specifically to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells.
Blinatumomab was granted breakthrough therapy, priority review, and orphan drug designations by FDA and is now approved in the U.S. for the treatment of Ph– relapsed or refractory B-cell precursor ALL.
In November 2015, blinatumomab was granted conditional marketing authorization in the European Union for the treatment of adults with Ph– relapsed or refractory B-cell precursor ALL.
Source: Amgen; September 1, 2016.