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.
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Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.
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.
Japan’s decision gives quizartinib its first approval globally in specific first-line AML indication, in relatively small but high-need patient population.