Amgen’s Blincyto (blinatumomab) Receives EU Expanded Indication Approval for Ph- CD19 Positive B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

 Amgen’s Blincyto (blinatumomab) Receives EU Expanded Indication Approval for Ph- CD19 Positive B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

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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Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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