The Food and Drug Administration (FDA) has granted full approval to Blincyto® (blinatumomab) for the treatment of patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
The conversion to regular approval was based on additional data from two phase 3 studies. In March 2018, Blincyto was granted accelerated approval for this indication based on data from the open-label, multicenter, single-arm phase 2 BLAST study (ClinicalTrials.gov Identifier: NCT01207388).
“We are pleased the FDA has granted full approval for Blincyto, the first FDA-approved CD19-directed CD3 T-cell engager BiTE® immunotherapy and the first to be FDA-approved for MRD in 2018,” said David M. Reese, MD, executive vice president of Research and Development at Amgen. “Today’s full approval underscores the clinical benefit of Blincyto for people living with B-ALL, and we look forward to exploring how we can continue to make a significant impact for these patients.”
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Blincyto is available as a 35mcg strength lyophilized powder for intravenous (IV) infusion after reconstitution.
This article originally appeared on MPR
