The U.S. Food and Drug Administration (FDA) has accepted for review Amgen’s Biologics License Application for blinatumomab for the treatment of adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). As part of the acceptance, the FDA granted blinatumomab priority review with a Prescription Drug User Fee Act action date of May 19, 2015. Blinatumomab is an investigational bispecific T-cell engager (BiTE) antibody construct designed to direct the body’s T cells against CD19-expressing target cells.
The application includes data from a phase II trial in adult patients with Philadelphia chromosome–negative relapsed/refractory B-precursor ALL treated with blinatumomab, which met its primary endpoint.
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 to cancer cells and inducing apoptosis. ■