Gemtuzumab ozogamicin (GO) is a humanized monoclonal antibody anti-CD33 conjugated with calicheamicin and was indicated for acute myeloid leukemia (AML) patients. It was initially approved in 2000 by FDA thank to promising results from a phase II trial including elderly relapsing AML patients. Numerous studies evaluated this treatment as salvage and frontline therapy in various regimens including associations with intensive chemotherapy. Based on the results from a randomized phase III trial, this agent was withdrawal because of no evidence for its benefit in terms of survival associated with excessive toxicity. Other phase III trials were then reported and show potentially better efficacy/toxicity profile. We review here the results of main trials interesting this agent, which is so far only available in a compassionate ATU program in France for the treatment of relapsing CD33+ AML patients.
Keywords: CD33; acute myeloid leukemia; gemtuzumab ozogamicin; monoclonal antibodies.