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FDA Panel Votes Against Quizartinib for AML

Jason M. Broderick @jasoncology
Published: Tuesday, May 14, 2019

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8-3 against approving a new drug application (NDA) for quizartinib for adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia (AML).

“I voted no based on the data available. The efficacy results that we were shown are a modest 6 weeks. And if I felt confident in those data, that would have been enough for me in the setting of AML, but a lot of the questions that were raised with respect to bias, confounding, and I do think the issue of equipoise is a real one in the setting of this particular study—it raises questions about whether or not that survival benefit is real,” said Heidi D. Klepin, MD, associate professor of Internal Medicine, Section of Hematology and Oncology, Wake Forest University Health Sciences.


Patients on QuANTUM-R were randomized in a 2:1 ratio to once-daily quizartinib at 60 mg, with a 30-mg lead-in (n = 245) or to receive investigators’ choice of salvage chemotherapy that was selected prior to randomization. Chemotherapy choices included low-dose cytarabine (n = 29); the combination of mitoxantrone, etoposide, and cytarabine, (MEC; n = 40); or the combination of fludarabine, cytarabine and GCSF with idarubicin (FLAG-IDA; n = 53).

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