inotuzumab ozogamicin

Ligand id: 8266

Name: inotuzumab ozogamicin

No information available.
Summary of Clinical Use
The EMA has granted inotuzumab ozogamicin orphan designation for the treatment of the rare disease B-cell acute lymphoblastic leukemia (ALL).
Although Phase 3 clinical trials assessing inotuzumab ozogamicin as a treatment for non-Hodgkin lymphoma have been terminated (NCT01232556 and NCT00562965) because they were unlikely to meet their primary objective of improving overall survival (OS), a separate Phase 3 trial in patients with ALL is ongoing (NCT01564784). Preliminary results from this ALL trial indicated extended progression-free and overall survival with inotuzumab ozogamicin compared to standard therapy [2]. The FDA granted breakthrough therapy designation for inotuzumab ozogamicin for ALL based on these results. The EMA had granted orphan designation for ALL in 2013. Both the EMA and FDA converted to full approval as a treatment for ALL in 2017. Veno-occlusive liver disease was observed as a major adverse event associated with inotuzumab ozogamicin therapy.
Mechanism Of Action and Pharmacodynamic Effects
Calicheamicin γ1 damages DNA by causing strand breaks, this ultimately leads to cell death. Antibody targeting of this cytotoxic agent to specific cells limits bystander damage.
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