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Home » Daiichi Sankyo’s Blood Cancer Drug Snagged

Daiichi Sankyo’s Blood Cancer Drug Snagged

July 2, 2019

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.

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