- The European Medicines Agency (EMA) validated Daiichi Sankyo's ( OTCPK:DSKYF ) ( OTCPK:DSNKY ) application seeking approval of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation standalone therapy after consolidation, to treat adult patients with newly diagnosed acute myeloid leukemia (AML) which is FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive.
- The EMA's Committee for Medicinal Products for Human Use (CHMP) will now review the marketing authorization application (MAA).
- The MAA was backed by data from a phase 3 trial, dubbed QuANTUM-First, the company said in an Aug. 23 press release.
For further details see:
Daiichi Sankyo's quizartinib gets EMA review to treat blood cancer subtype