FDA approves Pfizer's Mylotarg for AML

On Friday, FDA approved a BLA from Pfizer Inc. (NYSE:PFE) for Mylotarg gemtuzumab ozogamicin to treat adults with newly diagnosed, CD33-positive acute myelogenous leukemia and for relapsed or refractory CD33-positive AML in adults and in pediatric patients ages 2 and older. The pharma could not be reached for launch or pricing details.

In 2010, Pfizer withdrew Mylotarg from the market at FDA’s request after it failed to show a survival benefit and produced a significantly higher rate of fatal induction toxicity vs. chemotherapy alone in a postmarketing trial in AML patients. Mylotarg received accelerated approval in 2000. The current approval includes a lower recommended dose and a different dose schedule (see BioCentury Extra, June 21, 2010)...