Federal regulators have told officials at Daiichi Sankyo that their proposed blood cancer medicine isn’t ready for prime time.
The Tokyo-based firm said it received a complete response letter from the FDA about its drug quizartinib. The company did not spell out the agency’s objections, but the letter comes a little more than a month after an FDA advisory panel voted against quizartinib over concerns about the drug’s survival rates.
Quizartinib’s application also was missing data needed to make a case for treating adults with relapsed or refractory acute myeloid leukemia, the expert panel said. The vote was 8-3 against Daiichi Sankyo’s application.
The FDA’s PDUFA decision date for quizartinib is Aug. 25. The company said it is weighing its next steps.