inotuzumab ozogamicin (Besponsa)

^[1]^[2]^[3]

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]

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]

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.

↑ 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
↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/27292104 Free PMC Article
↑ ^3.0 ^3.1 ^3.2 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: https://www.ncbi.nlm.nih.gov/pubmed/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: https://www.ncbi.nlm.nih.gov/pubmed/37883737 https://ascopubs.org/doi/10.1200/JCO.23.01726