Amgen gains early US win for BiTE antibody Blincyto

Well ahead of its 19 May 2015 Prescription Drug User Fee Act action date, Amgen’s bispecific T-cell engager (BiTE) antibody Blincyto (blinatumomab) won the FDA’s blessing on 3 December to enter the US market as a treatment for 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.