Quizartinib to treat relapsed FLT3-ITD AML in Japan

August 6, 2019 0 By FM

Japanese ministry of health has approved quizartinib (Vanflyta), an oral FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukaemia (AML), as detected by an MHLW-approved test.

Approval of quizartinib is based on the results from the global pivotal phase 3 QuANTUM-R study and a phase 2 study of quizartinib in Japan in patients with relapsed/refractory FLT3-ITD AML. Results from QuANTUM-R, which was the first randomized phase 3 study to show that a FLT3 inhibitor prolonged overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/ refractory FLT3-ITD AML, were recently published in The Lancet Oncology.

Results of the global, phase 3 QuANTUM-R study demonstrated a statistically significant improvement in overall survival when comparing quizartinib to salvage chemotherapy. The hazard ratio for quizartinib was 0.76, and the median overall survival was 6.2 months in patients receiving quizartinib compared to 4.7 months salvage chemotherapy.

Quizartinib has been granted Breakthrough Therapy designation for the treatment of adult patients with relapsed/refractory FLT3-ITD AML by the FDA; Fast Track designation for the treatment of relapsed/refractory AML by the FDA; and, also has been granted Orphan Drug designation by both the FDA and the European Commission (EC) for the treatment of AML and by the Japan MHLW for the treatment of FLT3-mutated AML.