It was not until the end of July that the US-American FDA devoted "Breakthrough Therapy designation" to the antibody blinatumomab. Officially stated as a therapeutic breakthrough, the project now moves to the fast lane: based on very promising phase II data the FDA has now taken the application for priority review. A decision could fall to May, 2015. Also in the European EMA a corresponding dossier was submitted.
The immunomolecule is directed simultaneously against the CD3 receptor on T cells and against the surface protein CD19 on B cells (thus acting 'bispecific'). In this manner, the immune system is to be activated against tumors. Amgen developed the first molecule for use in certain forms of acute lymphoblastic leukemia. At this year's ASCO congress in the USA presented data show that about 43% of patients treated with blinatumomab achieved a complete remission or a complete remission with a general normalization of blood counts.
The artificial bispecific antibody was originally developed by Micromet in Munich. Amgen acquired the formerly Nasdaq-listed company in June 2012 with a 880 million-euro (1.2 billion US Dollar) takeover to access not only this molecule but the whole BiTE-technology platform.
Source: Amgen, clinicaltrials.gov