FDA Grants Full Approval For Blincyto To Treat MRD-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
“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, M.D., 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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