Blinatumomab Now Indicated for Children with Acute Lymphoblastic Leukemia

The FDA has expanded the use of Amgen's blinatumomab (Blincyto) to treat Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in pediatric patients.

The FDA has expanded the use of Amgen’s blinatumomab (Blincyto) to treat Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in pediatric patients.

Blincyto is a bispecific CD19-directed CD3 T-cell engager antibody construct that has previously been granted breakthrough therapy, priority review, and orphan drug designations by the FDA. It binds to CD19 on the surface of cells of B-lineage origin, as well as CD3 on the surface of T cells. It is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump, which should be programmable, lockable, nonelastomeric, and have an alarm.

The drug’s latest indication is based on results from a Phase 1/2 open-label, single-arm, multicenter trial designed to evaluate its safety and efficacy in pediatric patients with relapsed or refractory B-cell precursor ALL. With treatment completed, the study’s subjects are now being monitored for long-term efficacy.

Potentially life-threatening or fatal cytokine release syndrome and neurological toxicities have been reported in some patients who received Blincyto. Other warnings and precautions included in the drug’s label are serious infections, tumor lysis syndrome, neutropenia and febrile neutropenia, effects on driving ability, elevated liver enzymes, pancreatitis, and leukoencephalopathy.

Pharmacists should also be aware of the risk for preparation and administration errors, including underdose and overdose. Plus, vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of treatment, during treatment, and until immune recovery following the last cycle of Blincyto.