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)...
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