EC Approves Quizartinib Plus Chemotherapy for Newly Diagnosed FLT3-ITD AML

Quizartinib (VANFLYTA) has been approved in the European Union (EU) for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.

Quizartinib is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD-positive AML, which represents approximately 25% to 30% of all new AML cases, according to a press release from the manufacturer of the drug.

The authorization by the European Commission (EC) is based on results from the QuANTUM-First trial, which were published in The Lancet. The trial included patients who had newly diagnosed FLT3-ITD AML. It showed a 22% reduction in the risk of death compared with standard chemotherapy alone in patients who received quizartinib plus standard cytarabine and anthracycline induction, standard cytarabine consolidation, and continued maintenance monotherapy following consolidation. Investigators evaluated the safety of quizartinib in 265 patients who received it once daily during the trial.

“This approval of VANFLYTA represents an important advancement for frontline treatment of patients with FLT3-ITD-positive acute myeloid leukemia, an aggressive and historically difficult-to-treat subtype,” said Richard Schlenk, MD, a Professor and Head of the Trial Center of the National Center of Tumour Diseases at Heidelberg University Hospital and German Cancer Research Center. “VANFLYTA is a potent and selective FLT3 inhibitor that significantly improved overall survival when added to standard chemotherapy, and it will be a valuable treatment option for newly diagnosed FLT3-ITD-positive AML.”