Quizartinib recommended for approval in the EU

On September 15, 2023, quizartinib, an oral, highly potent and selective type II FLT3 inhibitor previously covered by the AML Hub, was recommended for approval in the European Union (EU) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of patients with newly diagnosed (ND) acute myeloid leukemia (AML) with FLT3-internal tandem duplication (FLT3-ITD) mutations in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib as a maintenance monotherapy.¹ Quizartinib was also recently approved in the US and in Japan for the same indication.

This positive opinion is based on results from the phase III QuANTUM-First trial (NCT02668653), which were previously reported by the AML Hub.¹ Quizartinib, in combination with standard chemotherapy, was associated with improved overall survival versus standard chemotherapy alone in patients with ND FLT3-ITD mutated AML.¹