Daiichi Sankyo’s long wait for approval of quizartinib just grew a little longer. Having bounced back from a 2019 rejection, the Japanese drugmaker has now learned the FDA needs another three months to review its second attempt to launch a challenger to Astellas and Novartis in a blood cancer market.

The US Food and Drug Administration (FDA) has granted priority review for Daiichi Sankyo’s quizartinib along with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy to treat newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML).

Three years after Daiichi Sankyo’s FLR3 inhibitor quizartinib was rejected by the FDA, the drugmaker has reported the results of a new phase 3 trial that is key to getting the drug to the US market and chasing down rival drugs from Astellas and Novartis.

Japan’s Daiichi Sankyo Co said on Friday the U.S. Food and Drug Administration has declined to approve its drug quizartinib as a treatment for adults with a type of blood cancer.

Daiichi Sankyo’s hope for a regulatory approval of its acute myeloid leukemia therapy quizartinib hit a snag after an advisory panel with the U.S. Food and Drug Administration (FDA) overwhelmingly voted against the medication due to safety concerns.

The FDA has questioned the reliability of the phase 3 results Daiichi Sankyo hopes will win it approval for quizartinib in acute myeloid leukemia. Officials raised the concerns in a briefing document to support an upcoming advisory committee meeting.

Novartis’ FLT3 inhibitor Rydapt was a much-welcomed addition to the armamentarium against acute myeloid leukemia when it was approved last year. Now, Daiichi Sankyo has data that could allow it to file its new-generation rival for approval.