- The U.S. Food and Drug Administration (FDA) granted priority review to Daiichi Sankyo's ( OTCPK:DSKYF ) ( OTCPK:DSNKY ) quizartinib to treat certain patients with a type of blood cancer.
- The FDA accepted a new drug application (NDA) for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy after consolidation, to treat adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive, the Japanese drugmaker said in a press release on Monday.
- The FDA is expected to make a decision by April 24, 2023. Under priority review, the FDA's goal is to take action within six months, compared to 10 months under standard review.
- The NDA was backed by data from a phase 3 trial, dubbed QuANTUM-First.
- Quizartinib is also under review in the EU for similar use.
For further details see:
Daiichi Sankyo's quizartinib gets FDA priority review to treat blood cancer subtype