Drugs / Quizartinib
Quizartinib
also known as
AC220 · AC-010220 · AC-010220 DIHYDROCHLORIDE · AC-220 DIHYDROCHLORIDE · AC010220 2HCL · AC220 (QUIZARTINIB) · AC220 2HCL · AC708 · +5 more
Small molecule targets CSF1R, FLT3, KIT, RET via inhibition
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute megakaryoblastic leukemia in adult 5 milestones | |||||
| Refused (EMA) | EU (EMA) | — | acute megakaryoblastic leukemia in adult | 2019-10-21 | “Daiichi Sankyo Receives Negative CHMP Opinion for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/ Refractory FLT3-ITD AML” daiichisankyo.com ↗ |
| Rejected (CRL) | US (FDA) | — | acute megakaryoblastic leukemia in adult | 2019-06-24 | “Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of quizartinib” daiichisankyo.com ↗ |
| Filed | US (FDA) | — | acute megakaryoblastic leukemia in adult | 2018-11-22 | “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” daiichisankyo.com ↗ |
| Filed | EU (EMA) | — | acute megakaryoblastic leukemia in adult | 2018-11-06 | “EMA Validates and Grants Accelerated Assessment of Marketing Authorization Application for Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Treatment of Patients with...” daiichisankyo.com ↗ |
| Filed | Japan (PMDA) | — | acute megakaryoblastic leukemia in adult | 2018-10-17 | “Daiichi Sankyo Submits Application in Japan for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML” daiichisankyo.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | EU (EMA) | Vanflyta | — | 2023-11-06 | europa.eu ↗ |
| Approved | US (FDA) | VANFLYTA | — | 2023-07-20 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Vanflyta | — | 2019-12-19 | europa.eu ↗ |
Trials 45
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04459585 | Aug → Oct 2020 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 116 trials | ||||||
| Phase 1 | NCT06769490 | Jul 2025 → Sep 2028 expected | acute myeloid leukemia | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06740825 | Oct → Dec 2024 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT06772246 | Oct 2024 → Jun 2025 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT06740799 | Sep 2024 → Oct 2026 expected | — | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 1 | NCT04796831 | Apr → Jun 2021 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT04473664 | Sep 2020 → Jul 2021 | liver disease, severe congenital | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT04459598 | Aug → Oct 2020 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT03552029 | Dec 2018 → Apr 2021 | acute myeloid leukemia | Daiichi Sankyo | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03723681 | Nov 2018 → Mar 2022 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT02834390 | Aug 2016 → Oct 2017 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT02675478 | Feb 2016 → Nov 2018 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT01468467 | Apr 2012 → Mar 2015 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT01390337 | Oct 2011 → Feb 2015 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT01411267 | Sep 2011 → Sep 2013 | childhood acute lymphoblastic leukemia, childhood acute myeloid leukemia | Therapeutic Advances in Childhood Leukemia Consortium | Completed | No outcome recorded |
| Phase 1 | NCT01049893 | Jan 2010 → Nov 2011 | cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT00462761 | Jan 2007 → Mar 2009 | acute myeloid leukemia, myelodysplastic syndrome | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT04687761 | Nov 2020 → Nov 2024 | acute myeloid leukemia | PETHEMA Foundation | Completed | No outcome recorded |
| Phase 1/2 | NCT04493138 | Jul 2020 → Dec 2027 expected | chronic myelomonocytic leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04128748 | May 2020 → Dec 2027 expected | acute myeloid leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04112589 | Dec 2019 → Dec 2023 | acute myeloid leukemia | PETHEMA Foundation | Unknown | No outcome recorded |
| Phase 1/2 | NCT04047641 | Oct 2019 → Dec 2027 expected | acute biphenotypic leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03735875 | Jan 2019 → Jul 2023 | acute myeloid leukemia, FLT3 internal tandem duplication | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT03661307 | Oct 2018 → Jan 2028 expected | acute myeloid leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03793478 | Aug 2018 → May 2027 expected | acute myeloid leukemia | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01892371 | Nov 2013 → Feb 2023 | acute myeloid leukemia, FLT3 internal tandem duplication, chronic myelomonocytic leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01236144 | Apr 2011 → Dec 2013 | acute myeloid leukemia, myelodysplastic syndrome | Cardiff University | Completed | No outcome recorded |
| Phase 211 trials · 1 met primary | ||||||
| Phase 2 | NCT07862517 | Jan → Dec 2027 expected | acute myeloid leukemia | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06824168 | Jul 2025 → Jun 2028 expected | acute myeloid leukemia | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 2 | NCT05564390 | Jun 2024 → May 2029 expected | acute myeloid leukemia with multilineage dysplasia, myelodysplastic syndrome | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06262438 | Feb 2024 → Jun 2028 expected | childhood acute myeloid leukemia | Princess Maxima Center for Pediatric Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT03989713 | Jul 2020 → Sep 2022 | acute myeloid leukemia | Prof. Dr. Richard F Schlenk | Terminated | No outcome recorded |
| Phase 2 | NCT04209725 | Jun 2020 → Apr 2021 | acute myeloid leukemia | SCRI Development Innovations, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04107727 | Sep 2019 → Oct 2024 | acute myeloid leukemia | PETHEMA Foundation | Completed | Met primary |
| Phase 2 | NCT03135054 | Oct 2017 → Oct 2020 | acute myeloid leukemia, FLT3 internal tandem duplication | The University of Hong Kong | Unknown | No outcome recorded |
| Phase 2 | NCT02984995 | Dec 2016 → Mar 2018 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT01565668 | Apr 2012 → Mar 2015 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT00989261 | Nov 2009 → Sep 2012 | acute myeloid leukemia | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07425808 | Dec 2026 → Oct 2028 expected | acute myeloid leukemia | European Organisation for Research and Treatment of Cancer - EORTC | Not yet recruiting | No outcome recorded |
| Phase 35 trials · 2 met primary | ||||||
| Phase 3 | NCT07478991 | Jul 2026 → Apr 2030 expected | acute myeloid leukemia | PETHEMA Foundation | Recruiting | No outcome recorded |
| Phase 3 | NCT06578247 | Nov 2024 → Jun 2030 expected | leukemia | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04676243 | May 2022 → May 2025 | acute myeloid leukemia | University Hospital Heidelberg | Withdrawn | No outcome recorded |
| Phase 3 | NCT02668653 | Sep 2016 → Aug 2021 | acute myeloid leukemia | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT02039726 | May 2014 → Feb 2018 | acute myeloid leukemia | Daiichi Sankyo | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT03746912 | — | acute myeloid leukemia | Daiichi Sankyo | No longer available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT05735184 Background | Jul 2023 → Apr 2030 expected | acute myeloid leukemia with mutated NPM1, acute myeloid leukemia, MLL gene rearrangement, myeloid sarcoma | Kura Oncology, Inc. | Recruiting | No outcome recorded |
| Phase 2/3 | NCT02272478 Comparator | Oct 2014 → Feb 2021 | acute myeloid leukemia, myelodysplastic syndrome | Cardiff University | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2019-10-21 | Daiichi Sankyo | Regulatory Daiichi Sankyo Receives Negative CHMP Opinion for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/ Refractory FLT3-ITD AML daiichisankyo.com ↗
Daiichi Sankyo Receives Negative CHMP Opinion for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/ Refractory FLT3-ITD AML |
| 2019-06-24 | Daiichi Sankyo | Regulatory Daiichi Sankyo Provides Update on FDA Review of Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗
today announced that the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of quizartinib |
| 2019-06-18 | Daiichi Sankyo | Regulatory Daiichi Sankyo’s VANFLYTA® Receives Approval in Japan for the Treatment of Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗
VANFLYTA® (quizartinib) is a FLT3 inhibitor MHLW-approved based on a survival benefit compared to salvage chemotherapy in adult patients with relapsed/refractory FLT3-ITD AML |
| 2019-05-15 | Daiichi Sankyo | Regulatory 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 daiichisankyo.com ↗ |
| 2019-04-05 | Daiichi Sankyo | Regulatory Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗
The FDA extended the action date by three months to allow time to review additional data submitted by Daiichi Sankyo in association with an FDA request. |
| 2018-11-22 | Daiichi Sankyo | Regulatory 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 daiichisankyo.com ↗
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 |
| 2018-11-06 | Daiichi Sankyo | Regulatory EMA Validates and Grants Accelerated Assessment of Marketing Authorization Application for Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗
EMA Validates and Grants Accelerated Assessment of Marketing Authorization Application for Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML |
| 2018-10-17 | Daiichi Sankyo | Regulatory Daiichi Sankyo Submits Application in Japan for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labor and Welfare (MHLW) for marketing approval of quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). |
| 2018-09-11 | Daiichi Sankyo | Regulatory Daiichi Sankyo’s FLT3 Inhibitor Quizartinib Receives Orphan Drug Designation from Japanese MHLW for FLT3-Mutated AML daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that quizartinib, an investigational FLT3 inhibitor, has been granted Orphan Drug designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of FLT3-mutated acute myeloid leukemia (AML). |
| 2018-08-01 | Daiichi Sankyo | Regulatory FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s FLT3 Inhibitor Quizartinib for Relapsed/Refractory FLT3-ITD AML daiichisankyo.com ↗
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). |
| 2018-06-18 | Daiichi Sankyo | Results Phase 3 QuANTUM-R Study Demonstrates Daiichi Sankyo’s Quizartinib Significantly Prolongs Overall Survival as Single Agent Compared to Chemotherapy in Patients with Relapsed/Refractory AML with FLT3-ITD Mutations daiichisankyo.com ↗
Phase 3 QuANTUM-R Study Demonstrates Daiichi Sankyo’s Quizartinib Significantly Prolongs Overall Survival as Single Agent Compared to Chemotherapy in Patients with Relapsed/Refractory AML with FLT3-ITD Mutations |
| 2018-05-08 | Daiichi Sankyo | Results 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) daiichisankyo.com ↗
Quizartinib is the first FLT3 inhibitor to demonstrate improved overall survival compared with chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations, a very aggressive form of the disease associated with poor prognosis |
| 2014-09-17 | BioLineRx, Ltd. | Results BioLineRx Presents Positive Preclinical Results in Treatment for AML Patients with FLT3 Mutations biolinerx.com ↗
Additionally, the combination of BL-8040 with the FLT3 inhibitor AC220 (Quizartinib) in-vitro increased the apoptotic effect of AC220, from a 60% reduction to a 97% reduction in AML cell viability. |
| 2013-12-10 | BioLineRx, Ltd. | Results BioLineRx Presents Positive Preclinical Results of Acute Myeloid Leukemia Treatment at ASH Conference biolinerx.com ↗
The effects were even more robust in cells harboring the FLT3 mutation and a synergistic effect was observed when BL-8040 was combined with the FLT3 inhibitor AC220 (Quizartinib). |
All press releases naming this drug 17 releases
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 48 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Quizartinib | “A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects With FLT3-ITD Positive Relapsed or Refractory Acute...” NCT01565668 ↗40“Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial.” PMID 29859851 ↗ May 2018 “Safety and pharmacokinetics of quizartinib in Japanese patients with relapsed or refractory acute myeloid leukemia in a phase 1 study.” PMID 31359361 ↗ Jul 2019 “Safety and tolerability of quizartinib, a FLT3 inhibitor, in advanced solid tumors: a phase 1 dose-escalation trial.” PMID 30081867 ↗ Aug 2018 “Local SOC is "7+3" + Midostaurin (100 mg) or Quizartinib (35.4 mg)” NCT07425808 ↗ “Quizartinib: 40mg, p.o., Days: 4 - 21” NCT03989713 ↗ |
| Known as | AC-010220 | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC-010220 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC-220 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC010220 2HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC220 | “Phase 2 Open-label, Single-arm Study of Quizartinib (AC220) Monotherapy in Japanese Patients With FLT3-ITD Positive Refractory or Relapsed Acute Myeloid Leukemia” NCT02984995 ↗7“the 2nd generation FLT3 inhibitor AC220” NCT02272478 ↗ |
| Known as | AC220 (QUIZARTINIB) | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC220 2HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | AC708 | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | ASP2689 | “A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects With FLT3-ITD Positive Relapsed or Refractory Acute...” NCT01565668 ↗ |
| Known as | QUIZARTINIB (AC220) | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | quizartinib dihydrochloride | “Patients received quizartinib dihydrochloride (henceforth referred to as quizartinib) once daily throughout a 28-day treatment cycle.” PMID 30081867 ↗ Aug 2018 |
| Known as | Quizartinib hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Known as | Vanflyta | ChEMBL registry synonym — accepted as the source's own label CHEMBL576982 ↗ |
| Action | Inhibit | “Macrophage colony stimulating factor receptor inhibitor” CHEMBL576982 ↗3“Tyrosine-protein kinase receptor RET inhibitor” CHEMBL576982 ↗ “Stem cell growth factor receptor inhibitor” CHEMBL576982 ↗ “FLT3 inhibitor” PMID 29859851 ↗ May 2018 |
| Modality | Small molecule | “The oral second-generation bis-aryl urea tyrosine kinase inhibitor quizartinib” NCT03989713 ↗ |
| Route | Oral | “Patients received quizartinib once daily as an oral solution” PMID 29859851 ↗ May 2018 |
| Target | CSF1R | “Macrophage colony stimulating factor receptor inhibitor” CHEMBL576982 ↗ |
| Target | FLT3 | “quizartinib, a FLT3 inhibitor” PMID 30081867 ↗ Aug 2018 |
| Target | KIT | “Stem cell growth factor receptor inhibitor” CHEMBL576982 ↗ |
| Target | RET | “Tyrosine-protein kinase receptor RET inhibitor” CHEMBL576982 ↗ |