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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Long Road For Daiichi Sankyo’s Quizartinib Gets Longer As FDA Extends Review Time
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 Eyes First-Line AML Filings For Vanflyta On Positive Data
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.
Daiichi Sankyo Plays Long Game With Quizartinib Outside Japan
Japanese company Daiichi Sankyo has its eye on first-line FLT3-ITD AML indication after rejection of relapsed/refractory plans in EU and US.