FDA Reapproves Gemtuzumab For AML, Withdrawn Drug Reinstated

Gemtuzumab ozogamicin, a drug previously withdrawn from the market, has been re-approved by FDA for the treatment of acute myeloid leukemia (AML). After demonstration of its safety and efficacy in a clinical trial, FDA approved Gemtuzumab for newly-diagnosed CD33-positive AML in adults and relapsed or refractory CD33-positive AML in adults and ≥ 2-year pediatric patients. History 2000: Initially, Gemtuzumab ozogamicin was approved under an accelerated-approval process by the FDA in 2000 for older patients with CD33-positive AML who had experienced a relapse. 2004: A randomized phase 3 comparative controlled trial was initiated in accordance with the FDA accelerated-approval process .

However, the study was stopped prior to completion due to early toxicity. Fatal toxicity rate was significantly higher in the Gemtuzumab combination therapy group vs the standard therapy group. 2010:…