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Pfizer Hopes To Convince FDA With Event-Free Survival Data For Mylotarg

 
• By Michael Cipriano

US agency usually uses endpoint of overall survival to assess acute myeloid leukemia drugs; Mylotarg initially garnered accelerated approval in 2000, but was withdrawn when a confirmatory trial failed to show a clinical benefit. Now it's back before the Oncologic Drugs Advisory Committee.

Pfizer Inc. is hoping its event-free survival (EFS) efficacy endpoint for its acute myeloid leukemia (AML) candidate Mylotarg (gemtuzumab ozogamicin) will help to sway the US FDA's Oncologic Drugs Advisory Committee (ODAC) to vote in favor of approval nearly six years after it was withdrawn from the market following an accelerated approval in 2000.

A CD33-directed antibody-drug conjugate, Mylotarg is specifically designed for the treatment of adults with previously untreated, de novo CD33 positive AML in combination with daunorubicin

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