New Acute Myeloid Leukemia Treatment under FDA Review


Results of the recent QuANTUM-R study for Quizartinib have revealed a 24 percent improvement in survival rates compared to patients who received salvage chemotherapy, for cases of acute myeloid leukemia (AML) presenting the FLT3 mutation. The drug scored better numbers across the board than any other current therapy.

If approved, quizartinib has the potential to meaningfully advance treatment for patients with relapsed or refractory FLT3-ITD AML. Patients need more treatment options for this type of AML, which is particularly aggressive and difficult to treat. We are pleased that the FDA has filed our application for quizartinib for patients with relapsed or refractory FLT3-ITD AML, and granted priority review,” said Arnaud Lesegretain, Vice President of Daiichi Sankyo and Head of Oncology Research and Development.

The Priority Review designation that the agency already granted means that the drug showed considerable promise in treating serious diseases and conditions. It also entails that the time it would take for the FDA to review will be expedited.

Jorge E. Cortes, MD stressed on the importance of these developments saying: “FLT3-ITD mutated AML represents a high unmet need entity as patients with this aggressive form of the disease have an overall dismal prognosis as evidenced by low response rates to current available therapies, high risk of relapse and a shorter overall survival than those without this mutation.”

Quizartinib is the first FLT3 inhibitor to demonstrate significant improvements in overall survival rates compared to cytotoxic chemotherapy, the general approach.

These findings represent the first reported clinical data demonstrating that a single agent can significantly improve overall survival, suggesting that quizartinib could potentially help these patients live longer. Additionally, in the study, a higher proportion of patients received a stem cell transplant in the quizartinib arm compared to the chemotherapy arm”.

The drug was well received on the European and Asian markets and it is expected to be approved by the FDA.

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