FDA Issues a Complete Response Letter to Daiichi Sankyo as Reason for Quizartinib NDA Rejection

Jun 23, 2019 | FDA Response, NDA, PharmaWatch Challenge, Rejection

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The FDA provided a complete response letter to Daiichi Sankyo, alerting them as to the reasons why the new drug application (NDA) for quizartinib as a treatment of adult adults with relapsed/refractory FLT3-ITD—positive acute myeloid leukemia (AML) would not be approved.

Apparently, the FDA’s decision derives from a May 2019 recommendation from the organization’s Oncologic Drugs Advisory Committee (ODAC). The panel voted 8 to 3 that the available data did not definitively demonstrate that the benefit of quizartinib outweighed the potential risks.

What is Quizartinib?

Quizartinib is a small molecule receptor tyrosine kinase inhibitor, originated Ambit Biosciences, and acquired by Daiichi Sankyo, that is currently under development for the treatment of acute myeloid leukemia. Its molecule target is FLT3, also known as CD135 which a proto-oncogene is.

Fit3 mutations are among the most common mutations in acute myeloid leukemia due to internal tandem duplication of Flt3. The presence of this mutation is a marker of adverse outcome.


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