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Amgen gains early US win for BiTE antibody Blincyto

This article was originally published in Scrip

Executive Summary

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.

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