BRIEF—Quizartinib marketing authorization application validated by EMA

Japanese drugmaker Daiichi Sankyo today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive.

Validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

The application is based on data from the QuANTUM-First Phase III trial recently presented at the European Hematology Association Congress.

In QuANTUM-First, quizartinib combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and continued as monotherapy following consolidation, demonstrated a statistically-significant and clinically-meaningful improvement in overall survival (OS) in adult patients with newly-diagnosed FLT3-ITD positive AML 2 compared to chemotherapy alone.

Under the trade name Vanflyta, quizartinib was approved and launched in Japan in late 2019.