Amgen: FDA Grants Full Approval For BLINCYTO - Quick Facts

(RTTNews) - Amgen (AMGN) announced the FDA has approved the supplemental Biologics License Application for BLINCYTO for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease greater than or equal to 0.1%. The approval converts BLINCYTO's accelerated approval to a full approval.

David Reese, executive vice president of Research and Development at Amgen, said: "The 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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