FDA Grants Full Approval of Amgen’s Supplemental Biologics License Application for Leukemia Treatment

June 23, 2023

Amgen’s supplemental biologics license application (sBLA) for its leukemia treatment Blincyto has received full approval by the US Food and Drug Administration (FDA). The move comes based on new data from two phase 3 trials, upgrading the treatment’s accelerated approval to a full approval in the treatment of CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL).

According to PM Group, “Blincyto is a bispecific T-cell engager (BiTE) immune-oncology therapy that targets CD19 surface antigens on B cells. Helping the body’s immune system fight cancer by detecting and targeting malignant cells, BiTE molecules bring T cells nearer to cancer cells, thereby enabling T cells to inject toxins and cause cancer cell death.”

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(Source: PM Live, June 23rd, 2023)

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