FDA Supplemental Approval: Blinatumomab for Treatment of Relapsed and Refractory Precursor B-Cell Acute Lymphoblastic Leukemia

The Oncologist
E Dianne PulteRichard Pazdur

Abstract

On July 11, 2017, the Food and Drug Administration granted approval for blinatumomab for the treatment of relapsed or refractory (R/R) precursor B-cell acute lymphoblastic leukemia (ALL). Blinatumomab is a bispecific CD19-directed CD3 T-cell engager. The basis for the approval included results from two clinical trials, TOWER and ALCANTARA. TOWER, a randomized trial comparing overall survival in patients with Philadelphia chromosome (Ph)-negative R/R ALL receiving blinatumomab versus standard-of-care (SOC) chemotherapy, demonstrated a hazard ratio of 0.71 favoring blinatumomab (p = .012; median survival, 7.7 months with blinatumomab and 4.0 months with SOC chemotherapy). Complete remission (CR) rates were 34% for patients receiving blinatumomab and 16% for those receiving SOC. Adverse events were consistent with those observed in prior trials, with cytokine release syndrome and some neurologic events, including tremor, encephalopathy, peripheral neuropathy, and depression, observed more frequently in the blinatumomab arm, whereas neutropenia and infection were less common among patients receiving blinatumomab. Depression emerged as a rare but potentially severe neurologic event associated with blinatumomab. In ALCANTARA, a singl...Continue Reading

References

Sep 17, 2015·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Donna PrzepiorkaRichard Pazdur
Dec 22, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Arend von StackelbergLia Gore
Mar 2, 2017·The New England Journal of Medicine·Hagop KantarjianMax S Topp

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Citations

Sep 6, 2019·Hematological Oncology·Carolina SimioniLuca M Neri
Apr 15, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Nirali N ShahTerry J Fry
Dec 7, 2019·Hematology·Liora Schultz, Rebecca Gardner
Feb 27, 2020·Journal of Immunotoxicology·Cris KamperschroerOliver Thomas
Feb 25, 2019·Journal of Cancer Research and Clinical Oncology·Lin Yu, Jianhua Wang
Sep 26, 2020·Expert Review of Clinical Immunology·Regina M MyersDavid T Teachey
Jan 5, 2021·Journal of Infusion Nursing : the Official Publication of the Infusion Nurses Society·Matteo Amicucci, Italo Ciaralli
May 25, 2021·Frontiers in Immunology·Jiabing MaCheng Qian
Jul 24, 2021·Experimental Hematology·Wenjuan LiaoPatricia Ernst
Jan 11, 2022·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·James A DavisHamza Hashmi

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Methods Mentioned

BETA
flow cytometry

Clinical Trials Mentioned

NCT01466179
NCT02013167
NCT02000427
NCT01471782

Software Mentioned

TOWER

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