Inotuzumab ozogamicin

(Besponsa®)

Inotuzumab ozogamicin

Drug updated on 10/30/2024

Dosage FormInjectable (intravenous; 0.9 mg/vial)
Drug ClassCD22-directed antibody-drug conjugates (ADC)
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.

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Summary
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  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • Overall Survival (OS): Cluster of Differentiation (CD)-targeted immunotherapy significantly improved overall survival in acute lymphoblastic leukemia (ALL) patients compared to conventional chemotherapy, with a pooled OR (odds ratio) of 2.11 (95% CI (confidence interval), 1.76-2.53), demonstrating a robust survival benefit.
  • Relapse-Free Survival (RFS): Patients treated with CD-targeted immunotherapy had significantly higher relapse-free survival rates than those on conventional chemotherapy, with a pooled OR of 2.25 (95% CI, 1.62-3.14).
  • Complete Remission (CR) and Minimal Residual Disease (MRD) Negativity: CD-targeted immunotherapy led to higher rates of complete remission (OR 1.70, 95% CI 1.07-2.69) and minimal residual disease negativity (OR 2.98, 95% CI 1.17-7.58) compared to conventional chemotherapy.
  • Patients receiving CD-targeted immunotherapy for acute lymphoblastic leukemia had a significantly lower risk of febrile neutropenia compared to those receiving conventional chemotherapy, with a pooled OR of 0.22 (95% CI, 0.08-0.58).
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Besponsa (inotuzumab ozogamicin) Prescribing Information.2017Exeltis USA, Inc., Florham Park, NJ

Systematic Reviews / Meta-Analyses