Breakthrough status for Amgen’s blinatumomab in ALL

USA-based Amgen (Nasdaq: AMGN), the world's largest independent biotech firm, says that the US Food and Drug Administration has granted Breakthrough Therapy designation to investigational bispecific T cell engager (BiTE) antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

The Breakthrough designation was based on the results of a Phase II trial of 189 adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab. Data from the Phase II trial were most recently presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) and the 19th Congress of the European Hematology Association (EHA).

Strong basis for regulatory filing later this year