Quizartinib FDA 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 timeline for quizartinib
| Date | Article |
|---|
| Apr 21, 2023 | Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA |
| Oct 24, 2022 | Quizartinib Granted Priority Review in the U.S. for Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia |
| Jun 11, 2022 | Quizartinib Plus Chemotherapy Significantly Improved Overall Survival Compared to Chemotherapy in Patients with Newly Diagnosed FLT3-ITD Positive Acute Myeloid Leukemia |
| Nov 18, 2021 | Quizartinib Added to Chemotherapy Demonstrates Superior Overall Survival Compared to Chemotherapy Alone in Adult Patients with Newly Diagnosed FLT3-ITD Positive AML |
| Jun 21, 2019 | Daiichi Sankyo Provides Update on FDA Review of Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML |
| May 14, 2019 | Daiichi 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, 2019 | Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML |
| Nov 21, 2018 | FDA 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, 2018 | FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML |
| May 8, 2018 | Daiichi 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) |
Further information
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