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2024-03-08T07:28:32.000Z

Inotuzumab ozogamicin receives U.S. FDA approval for pediatric patients aged ≥1 year with CD22+ R/R B-ALL

Mar 8, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in ALL

On March 6, 2024, it was announced that the U.S. Food and Drug Administration (FDA) had approved inotuzumab ozogamicin for the treatment of pediatric patients aged 1 year and older with relapsed/refractory (R/R) CD22-positive B-cell precursor acute lymphoblastic leukemia (B-ALL). This approval is based on results from a multicenter, single-arm, open-label study.

The study included a total of 53 patients who were evaluated at two dose levels: (1) initial dose of 1.4 mg/m2/cycle (n = 12); and (2) 1.8 mg/m2/cycle (n = 41).

The key outcomes were as follows:

  • A complete remission (CR) rate of 42% was achieved in all patients.
  • A median duration of CR of 8.2 months was demonstrated.
  • An MRD negativity rate of 95.5% was reported based on flow cytometry and 86.4% based on real-time quantitative polymerase chain reaction for patients who achieved a CR.
  • The most commonly reported adverse reactions were: thrombocytopenia, pyrexia, anemia, vomiting, infection, hemorrhage, neutropenia, nausea, leukopenia, febrile neutropenia, increased transaminases, abdominal pain, and headache.

For the first cycle, the U.S. FDA has recommended an inotuzumab ozogamicin dose of 1.8 mg/m2 per cycle given as 3 fractionated doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2).

  1. S. Food & Drug Administration. FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-inotuzumab-ozogamicin-pediatric-patients-acute-lymphoblastic-leukemia. Published March 6, 2024. Accessed March 7, 2024.

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