Japan Nod For Quizartinib In First-Line AML
First FLT3 Inhibitor For Use
Japan’s decision gives quizartinib its first approval globally in specific first-line AML indication, in relatively small but high-need patient population.
You may also be interested in...
FDA action is expected on a handful of novel agents, including Daiichi Sankyo’s quizartinib, and conversion to full approval for Eisai/Biogen’s Leqembi.
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.