Astellas' Phase III Front-Line AML Study Of Xospata Fails
Standard Of Care Has Shifted Since Trial's Initiation
One expert said the company should focus efforts on developing the drug for maintenance treatment of AML.
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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.
Japan’s decision gives quizartinib its first approval globally in specific first-line AML indication, in relatively small but high-need patient population.
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.