Amgen's Blincyto (blinatumomab) Receives EU Expanded Indication Approval for Ph- CD19 Positive B-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Shots:
- The expanded approval is based on P-II BLAST study results assessing Blincyto (15ug/m2/d @4wks.) in patients with 3L + MRD-positive ALL in complete hematologic remission- evaluating its efficacy- safety- and tolerability
- The study resulted in complete MRD response or no detectable MRD- relapse-free survival- eliminating detectable residual disease with safe and effective results in the study
- Blincyto (blinatumomab) is a bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy and has received the US FDA approval for B-cell precursor ALL in first or second complete remission with MRD greater than or equal to 0.1 percent in adults and children
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