Just days after receiving approval in Japan, Daiichi Sankyo said the U.S. FDA will not approve its drug, quizartinib, as a treatment for adults with a type of blood cancer.
The agency's decision follows an advisory committee meeting in May where independent advisers to the FDA voted 8-3 against the drug’s approval to treat acute myeloid leukemia patients with a specific genetic mutation called FLT3.
The panel had specifically expressed concern over the modest survival results, lack of robust data, the high proportion of randomized but untreated patients, and the risk for QT prolongation with the treatment.
Daiichi Sankyo is evaluating the recent Complete Response Letter and will determine next steps in the U.S.
