Amgen seeks FDA nod for blinatumomab
This article was originally published in Scrip
Executive Summary
Amgen wants the FDA's blessing to market the firm's bispecific T-cell engager (BiTE) antibody blinatumomab as a treatment for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow, which has a median overall survival of just 3-5 months.