Quizartinib Marketing Authorization Application Validated by EMA for Treatment of Adult Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia
We look forward to working with the EMA to support their review of quizartinib as a potential option for patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia.
- We look forward to working with the EMA to support their review of quizartinib as a potential option for patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia.
- The application is based on data from the QuANTUM-First phase 3 trial recently presented at the European Hematology Association (#EHA2022) Congress.
- Patients were randomized 1:1 into two treatment groups to receive quizartinib or placebo combined with anthracycline- and cytarabine-based regimens.
- Quizartinib is currently approved for use in Japan for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an approved test.