Astellas Stays Ahead of Daiichi Sankyo In AML With CHMP Nod For Xospata
A positive opinion for its FLT3 inhibitor for acute myeloid leukemia gives Astellas a further advantage over its Japanese competitor's same-class offering, quizartinib.
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Japan grants first approval worldwide for Daiichi Sankyo's oral FLT3 inhibitor, marking progress for Japanese firm's global oncology ambitions.
Daiichi Sankyo made a strong case to rebut US FDA’s concerns about the 'credibility' of a survival benefit reported for its refractory AML therapy quizartinib in front of the Oncologic Drugs Advisory Committee. Then Richard Pazdur spoke.
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.