FDA delay throws off Daiichi Sankyo's timeline for quizartinib
The US regulator will not be able to complete its review of Daiichi Sankyo’s (TSE: 4568) submission for quizartinib within the expected timeframe.
The Japanese drugmaker is looking to market the FLT3 tyrosine kinase inhibitor for the first-line treatment of adults with FLT3-ITD-positive acute myeloid leukemia (AML).
While the firm had hoped for a decision imminently, the US Food and Drug Administration needs more time to review requested updates to the proposed Risk Evaluation and Mitigation Strategies (REMS).
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