NEW YORK – Daiichi Sankyo on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended its FLT3 inhibitor quizartinib plus chemotherapy, followed by quizartinib maintenance therapy, as an option for patients with newly diagnosed FLT3-internal tandem duplication (ITD)-positive acute myeloid leukemia.
CHMP recommended quizartinib specifically in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy. The committee's positive decision is based on data from the Phase III QuANTUM-First trial, which showed that the FLT3 inhibitor-containing regimen improved AML patients' overall survival compared to standard chemotherapy.
In July, the US Food and Drug Administration also relied on this data to approve the same indication for quizartinib, which is sold under the brand name Vanflyta.
Mark Rutstein, global head of oncology clinical development at Daiichi Sankyo, said in a statement that if the European Commission approves quizartinib based on CHMP's recommendation, it will be the first FLT3 inhibitor approved for newly diagnosed FLT3-ITD-positive AML.
Approximately 25 percent of AML patients harbor FLT3-ITD mutations.