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Dose optimization of inotuzumab ozogamicin for adult B-ALL
Test your knowledge! Take our quick quiz before and after you read this article to find out if you improved your knowledge. Results help us to improve content and continually provide open-access education.
Question 1 of 1
In the pooled studies B1931010 and INO-VATE and in the B1931030 study, which dose of inotuzumab ozogamicin had a greater clinical utility index?
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B
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Inotuzumab ozogamicin was approved by the FDA and EMA in 2017 for the treatment of adults with relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia. The FDA issued a post-marketing requirement due to concern that the proposed starting dose of 1.8 mg/m2/cycle of inotuzumab ozogamicin may not be optimal. The analysis, presented at ASH 2024 by DeAngelo, quantitatively measured the optimal trade-off between safety and efficacy using pooled data from the B1931010 and INO-VATE studies as well as data from the B1931030 study. These analyses support the current FDA-approved higher dose of 1.8 mg/m2/cycle, compared with the lower dose of 1.2 mg/m2/cycle, in balancing the efficacy and safety of inotuzumab ozogamicin in adult patients with relapsed/refractory acute lymphoblastic leukemia.
This educational resource is independently supported by Pfizer. All content was developed by SES in collaboration with an expert steering committee; funders were allowed no influence on the content of this resource.
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