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inotuzumab ozogamicin (Besponsa)

Indications: - treatment of refractory or relapsed B-cell ALL - inotuzumab ozogamicin + dexamethasone induction therapy can result in complete remission in older adults with Philadelphia chromosome-negative precursor B-cell ALL [3] Dosage: - 1.8 mg/m2 per 21-day cycle - administered as 3 divided doses on day 1 (0.8 mg/m2) & on days 8 & 15 (0.5 mg/m2) - dose for subsequent cycles is dependent on response following first cycle - for use in combination with dexamethasone [3] Adverse effects: - thrombocytopenia, anemia, hemorrhage - leukopenia, neutropenia (including febrile neutropenia), infection - fatigue, fever, nausea, headache - elevated serum transaminase levels, elevated serum bilirubin, abdominal pain * Boxed warning: potentially severe hepatotoxicity Mechanism of action: - binds B-cell ALL cancer cells that express CD22 antigen, allowing a covalently linked toxin to penetrate the cells, inhibit their growth, & induce cell death.

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

General

antineoplastic monoclonal antibody

References

  1. Bankhead C FDA Approves Drug for ALL Subgroup - Inotuzumab ozogamicin for relapsed/refractory B-cell ALL MedPage Today. August 17, 2017 https://www.medpagetoday.com/HematologyOncology/Leukemia/67349 - Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871 - U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
  2. Kantarjian HM, DeAngelo DJ, Stelljes M et al Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. Epub 2016 Jun 12. PMID: 27292104 Free PMC Article
  3. Stelljes M et al. Inotuzumab ozogamicin as induction therapy for patients older than 55 years with Philadelphia chromosome-negative B-precursor ALL. J Clin Oncol 2024 Jan 20; 42:273 PMID: 37883727 https://ascopubs.org/doi/10.1200/JCO.23.00546 - Logan A. Innovating simpler and less toxic frontline management for adults with ALL. J Clin Oncol 2024 Jan 20; 42:250. PMID: 37883737 https://ascopubs.org/doi/10.1200/JCO.23.01726