Quizartinib (Daiichi Sankyo), an FLT3 Inhibitor under investigation for the treatment of adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML), has been granted Breakthrough Therapy designation by the Food and Drug Administration.

The designation was based on results from the Phase 3 QuANTUM-R trial, which included 367 participants who were randomized to receive quizartinib or salvage chemotherapy (SC). Results showed that patients who received quizartinib had a 24% reduction in the risk of death compared to patients who received SC (hazard ratio 0.76, P=.0177, 95% CI 0.58-0.98); median overall survival was 6.2 months for quizartinib-treated patients and 4.7 months for patients treated with SC. The estimated survival probability at 1 year was 27% for the quizartinib group and 20% for the SC arm. The incidence of treatment-emergent adverse events was comparable between patients who received single agent quizartinib and those who received SC.

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“There have been limited advances over the past several decades for the treatment of relapsed/refractory FLT3-ITD AML, a very aggressive form of the disease associated with poor prognosis,” said Arnaud Lesegretain, VP, Oncology Research and Development Head, Daiichi Sankyo. “Quizartinib is the first FLT3 inhibitor to significantly improve overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory AML with FLT3-ITD, an underlying driver of this subtype of AML.”

For more information visit DaiichiSankyo.com.