Quizartinib Looks Like A Good Drug, ODAC Says, But Needs Another Efficacy Trial Before Approval
US FDA's Oncologic Drugs Advisory Committee voted 8-3 against approval for Daiichi's quizartinib, although panelists felt the acute myeloid leukemia candidate would be approvable with another trial to better characterize its efficacy.
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After over a decade in development, Vanflyta scored FDA approval in newly diagnosed FLT3-ITD acute myeloid leukemia, where Novartis FLT3 inhibitor Rydapt has been on the market for years.
The drug could nevertheless find itself in a competitive position if approved for frontline FLT3-ITD acute myeloid leukemia, especially as competitor Astellas’s Xospata has repeatedly stumbled.
Daiichi Sankyo is aiming to overcome past US and EU setbacks for its FLT3 inhibitor Vanflyta with planned filings for first-line AML on the back of positive new Phase III data.