FDA Accepts Amgen’s BLA for BlinatumomabBy
Amgen reports that the US Food and Drug Administration has accepted for review the company’s biologics license application (BLA) for the investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow. As part of the acceptance, the FDA granted blinatumomab priority review with a Prescription Drug User Fee Act action date of May 19, 2015.
A marketing authorization application (MAA) has also been submitted to the European Medicines Agency (EMA) via the centralized procedure for approval to market blinatumomab for the treatment of adults with Ph- relapsed/refractory B-precursor ALL.
BiTE antibody constructs represent an immunotherapy approach that helps the body’s immune system target cancer 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. BiTEantibody 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).
Blinatumomab, the first of the investigational BiTE antibody constructs, has received orphan drug designation from the EMA and breakthrough therapy and priority review designation from the FDA for the treatment of ALL. According to the FDA, priority review designation is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. A priority review designation will set a goal date for taking action on an application within six months of receipt.