BioCentury
ARTICLE | Company News

Accelerated approval for Blincyto in new ALL indication

March 29, 2018 6:46 PM UTC

FDA granted accelerated approval to Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN) to treat B cell precursor acute lymphoblastic leukemia in patients who are in remission but still have minimal residual disease (MRD). The bispecific T cell engager (BiTE) against CD19 is the first drug FDA has approved to treat the condition.

This month, FDA’s Oncologic Drugs Advisory Committee voted 8-4 that data from the Phase II BLAST trial showed Blincyto’s benefits outweigh its risks in treating MRD-positive B cell precursor ALL. The drug has full approval for relapsed or refractory B cell precursor ALL (see BioCentury Extra, March 7)...

BCIQ Company Profiles

Amgen Inc.

BCIQ Target Profiles

CD19