Gemtuzumab ozogamicin (Myelotarg) was approved to treat patients aged 60 years and older with recurrent AML who were not considered candidates for other chemotherapy in 2000 by the FDA. The initial approval was based on the surrogate endpoint of response rate observed in 142 patients with AML across 3 clinical trials.
A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding gemtuzumab ozogamicin to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to patients with AML.
The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received gemtuzumab ozogamicin compared with those receiving chemotherapy alone.
At initial approval, gemtuzumab ozogamicin was associated with veno-occlusive disease, which can be fatal. This rate has increased in the post-market setting.
As a result Pfizer has voluntarily withdrawn Myelotarg from the market. It is no longer available for the treatment of AML. As such Myelotarg has been removed from the SAOC treatment guidelines for patients with AML with immediate effect.Back to the Bulletin Board
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