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FDA rejects quizartinib for acute myeloid leukemia subtype
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The FDA did not grant approval to quizartinib for the treatment of patients with FLT3-internal tandem duplication-positive relapsed or refractory acute myeloid leukemia.
This decision follows an Oncologic Drug Advisory Committee (ODAC) meeting in May during which, in a 3-8 vote, panelists concluded that study results failed to show that the benefits of quizartinib (Daiichi Sankyo) — an investigational FLT3 inhibitor — outweigh the risks for this population.
The panel specifically expressed concern over the modest survival results, lack of robust data, the high proportion of randomly assigned but untreated patients, and the risk for QT prolongation with the treatment.
“Daiichi Sankyo is evaluating the complete response letter and will determine next steps in the U.S.,” Antoine Yver, MD, MSc, executive vice president and global head of oncology research and development at Daiichi Sankyo, said in a press release.
Quizartinib received FDA breakthrough therapy designation and priority review for this application.