EC OKs Amgen’s Cancer Drug BlincytoBy
The European Commission (EC) has granted conditional marketing authorization for Amgen’s Blincyto (blinatumomab) for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL), a rare and rapidly progressing cancer of the blood and bone marrow.
Approval from the EC grants a centralized conditional marketing authorization with unified labeling in the 28 countries that are members of the European Union, Norway, Iceland, and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC. Conditional license requires the license to be renewed every year and it will be converted to full standard license once post-licensing commitments have been fulfilled.
Blincyto was granted orphan drug designation by the European Medicines Agency in 2009 for the treatment of ALL. Blincyto was granted breakthrough therapy and priority review designations by the US Food and Drug Administration and is approved in the US for the treatment of Ph- relapsed or refractory B-cell precursor ALL.
Blincyto 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. BiTE antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.