Daiichi Sankyo gets hard-fought FDA nod for AML drug

July 21, 2023

The U.S. FDA has approved Daiichi Sankyo's FLT3 inhibitor for treating newly diagnosed patients suffering from acute myeloid leukemia (AML), an aggressive type of blood cancer.

The treatment, branded Vanflyta, was approved for use in combination with the standard-of-care treatment cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for adult patients with FLT3-ITD positive AML — a specific gene mutation associated with increased risk of relapse. According to Daiichi Sankyo, Vanflyta is the first FLT3 inhibitor approved in the U.S. specifically for patients in this subset of AML.

The road to U.S. approval for quizartinib has not been short for the Japan-based drugmaker. In 2019, just days after receiving approval in Japan, the FDA turned down the treatment citing concern over the modest survival results, lack of robust data, the high proportion of randomized but untreated patients, and the risk for QT prolongation (heart rhythm disorder).

With positive trial data in hand, Daiichi Sankyo resubmitted its NDA. Then, this past April, the FDA extended the review period for the application, bumping the PDUFA date until late July. According to Daiichi Sankyo, the agency needed more time to review the proposed Risk Evaluation and Mitigation Strategies (REMS) included in the application.

Vanflyta is Daiichi Sankyo's third innovative oncology med to win U.S. approval.