7 New FDA Approvals Pharmacy Techs Should Know

OCTOBER 13, 2016
Ryan Marotta, Assistant Editor
Learn about the new products and expanded indications approved by the FDA in September 2016.
1.) Blincyto
The FDA expanded the indication of Amgen’s blinatumomab (Blincyto) on September 1, 2016.
Blincyto, a bispecific CD19-directed CD3 T-cell engager antibody construct administered as a continuous intravenous infusion, was initially approved in December 2014 for the treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia in adults. With the more recent FDA decision, the drug can now also be used for this purpose in children.
Adverse events associated with the administration or use of Blincyto include serious infections, tumor lysis syndrome, neutropenia and febrile neutropenia, impaired driving ability, elevated liver enzymes, pancreatitis, and leukoencephalopathy. Potentially life-threatening or fatal cytokine release syndrome and neurological toxicities have been reported in some patients treated with the drug.
Additionally, patients should not be immunized with live virus vaccines for at least 2 weeks prior to the start of treatment, during treatment, or until immune recovery following the last cycle of Blincyto.