The US Food and Drug Administration approved Amgen’s Blincyto (blinatumomab) for the treatment of patients with a certain rare form of acute lymphoblastic leukaemia (B-cell ALL). The drug is based on Amgen’s bispecific T cell engager (BiTE®) technology, designed to engage the body’s T cells, a type of immune cell, to destroy cancer cells. It connects CD3, a surface protein on T cells, with CD19, which is found on most B cells. It is the first anti-CD19 drug approved by the FDA. ‘Its unique therapeutic mode of action holds strong promise for cancer patients,’ comments Christian Stein, CEO of Ascenion. ‘Chemotherapy is currently the standard treatment. Patients who did not respond or whose cancer returned have had hardly any treatment options up to now. To these patients, Blincyto offers an entirely novel therapeutic modality that helps the body's own immune system fight the disease.’ The drug is also being developed for the treatment of other blood and bone marrow cancers. Further BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.
The approach is partly based on IP generated at the Max Delbrück Center for Molecular Medicine Berlin-Buch. It was initially developed by the Munich-based start-up Micromet, which was taken over by Amgen for USD 1.16 billion in 2012.
Further information at: <link http: www.fda.gov newsevents newsroom pressannouncements ucm425549.htm _blank external-link-new-window>FDA
