Amgen Submits sBLA for BlincytoBy
Amgen has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) for Blincyto (blinatumomab) to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Blincyto is a bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy that is currently available under an accelerated approval in the US for the treatment of Ph- relapsed or refractory B-cell precursor ALL, a rare and rapidly progressing cancer of the blood and bone marrow impacting both adults and children.
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. It was granted breakthrough therapy and priority review designations by the FDA, and is now approved in the US for the treatment of Ph- relapsed or refractory B-cell precursor ALL. It was also recently granted conditional marketing authorization in the European Union for the treatment of adults with Ph- relapsed or refractory B-precursor ALL.
Bispecific T cell engager (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.