FDA's ODAC to review new BLA for Pfizer's Mylotarg

FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet on July 11 to discuss a BLA for Mylotarg gemtuzumab ozogamicin. Pfizer Inc. (NYSE:PFE) is seeking its approval in combination with daunorubicin and cytarabine for previously untreated de novo acute myelogenous leukemia (AML).

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 (see BioCentury Extra, June 21, 2010)...