Pfizer Hopes To Convince FDA With Event-Free Survival Data For Mylotarg
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survival to assess acute myeloid leukemia drugs; Mylotarg initially garnered accelerated approval in 2000, but was withdrawn when a confirmatory trial failed to show a clinical benefit.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.
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Oncologic Drugs Advisory Committee votes 6-1 that benefits of Pfizer's Mylotarg outweigh risks, positioning drug for return to market after being withdrawn in 2010; vote could also open door for future acute myeloid leukemia products to use event-free survival as endpoint.