Drug: Gemtuzumab ozogamicin (Mylotarg, Pfizer)
Status: Approved for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia (AML) and patients aged 2 years and older with relapsed or refractory CD33-positive AML
Significant Information:
- Gemtuzumab ozogamicin (GO) originally received accelerated approval in May 2000 as monotherapy for older patients with CD33-positive AML who had experienced a relapse, but it was voluntarily withdrawn from the market after confirmatory