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Quizartinib Approval Status

FDA Approved: No
Generic name: quizartinib
Company: Daiichi Sankyo
Treatment for: Acute Myeloid Leukemia

Quizartinib is an oral FLT3-ITD (FMS-like tyrosine kinase-3-internal tandem duplication) inhibitor in development for the treatment of patients with acute myeloid leukemia (AML).

Development Status and FDA Approval Process for quizartinib

DateArticle
Jun 21, 2019Daiichi Sankyo Provides Update on FDA Review of Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
May 14, 2019Daiichi Sankyo Announces Outcome of FDA Oncologic Drugs Advisory Committee Meeting to Review FLT3 Inhibitor Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Apr  9, 2019Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Nov 21, 2018FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Aug  1, 2018FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML
May  8, 2018Daiichi Sankyo Announces Single Agent Quizartinib Significantly Prolongs Overall Survival Compared with Chemotherapy in Patients with Relapsed/Refractory AML with FLT3-ITD Mutations (QuANTUM-R Study)
Oct 11, 2016Daiichi Sankyo Announces First Patient Enrolled in Phase 3 QuANTUM-First Trial Investigating Quizartinib in Newly-Diagnosed FLT3-ITD+ Acute Myeloid Leukemia
Apr  8, 2014Ambit Announces Initiation Of Quizartinib QUANTUM-R Phase 3 Trial
Jun  4, 2013Ambit Announces Presentation of Results from Phase 2 ACE Study of Quizartinib
Dec 10, 2012Ambit and Astellas Announce Presentation of Results from Phase 2 ACE Study of Quizartinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) at the 54th Annual Meeting of the American Society of Hematology
Dec 13, 2011Ambit and Astellas Announce Results From Multiple Quizartinib Presentations at the 53rd Annual Meeting of the American Hematology Society

Further information

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