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Inotuzumab Ozogamicin: First Global Approval.

Yvette N Lamb1

  • 1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.

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|August 19, 2017
PubMed
Summary

Inotuzumab ozogamicin is an antibody-drug conjugate approved for treating relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). It targets CD22-expressing cells, delivering a cytotoxic agent to induce cancer cell death.

Area of Science:

  • Oncology
  • Immunotherapy
  • Pharmacology

Background:

  • Inotuzumab ozogamicin is an anti-CD22 monoclonal antibody-calicheamicin conjugate targeting CD22-expressing tumor cells.
  • The drug internalizes upon binding, releasing a cytotoxic agent that induces DNA damage and cell death.

Purpose of the Study:

  • To summarize the development milestones of inotuzumab ozogamicin leading to its first approval for acute lymphoblastic leukemia (ALL).

Main Methods:

  • Review of regulatory submissions and clinical trial data for inotuzumab ozogamicin.
  • Analysis of its mechanism of action as an antibody-drug conjugate.

Main Results:

  • In June 2017, the EMA approved inotuzumab ozogamicin as monotherapy for adult relapsed/refractory CD22-positive B-cell precursor ALL.

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  • Restrictions apply for Philadelphia chromosome-positive ALL patients who failed tyrosine kinase inhibitors.
  • Ongoing trials are evaluating inotuzumab ozogamicin in combination therapies and in pediatric ALL.

    • Conclusions:

    • Inotuzumab ozogamicin represents a significant advancement in the treatment of relapsed or refractory B-cell precursor ALL.
    • Its development highlights the success of targeted antibody-drug conjugate therapy in hematologic malignancies.