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CHMP Releases Positive Opinion for Quizartinib in Newly Diagnosed FLT3 ITD+ AML

The Committee for Medicinal Products for Human Use has recommended the approval of quizartinib in the European Union for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, followed by maintenance quizartinib, for adult patients with newly diagnosed acute myeloid leukemia. ....

Daiichi Sankyo , Mark Rutstein , European Union , Oncology Clinical Development , European Medicines Agency , Medicinal Products , Human Use , Flt3 Itd , Acute Myeloid Leukemia , Hematologic Malignancies , Committee For Medicinal Products Human Use , Phase 3 Quantum First Trial ,