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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR QUIZARTINIB DIHYDROCHLORIDE


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All Clinical Trials for Quizartinib Dihydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00462761 ↗ A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 Status Completed Daiichi Sankyo Inc. Phase 1 2007-01-01 Patients received oral AC220 daily for 14 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3 status.
NCT00462761 ↗ A Phase I Study of AC220 in Patients With Relapsed/Refractory Acute Myeloid Leukemia Regardless of FLT3 Status Completed Daiichi Sankyo, Inc. Phase 1 2007-01-01 Patients received oral AC220 daily for 14 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia, regardless of FLT3 status.
NCT01390337 ↗ A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML) Completed Ambit Biosciences Corporation Phase 1 2011-10-01 The purpose of this study is to define the maximum tolerated dose (MTD) of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation.
NCT01390337 ↗ A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML) Completed Daiichi Sankyo Inc. Phase 1 2011-10-01 The purpose of this study is to define the maximum tolerated dose (MTD) of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation.
NCT01390337 ↗ A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML) Completed Daiichi Sankyo, Inc. Phase 1 2011-10-01 The purpose of this study is to define the maximum tolerated dose (MTD) of AC220 when combined with induction and consolidation therapy and as maintenance therapy following induction and consolidation.
NCT01411267 ↗ AC220 for Children With Relapsed/Refractory ALL or AML Completed Ambit Biosciences Corporation Phase 1 2011-09-01 This is a phase I study of the investigational drug AC220 combined with cytarabine and etoposide in pediatric patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML).
NCT01411267 ↗ AC220 for Children With Relapsed/Refractory ALL or AML Completed Therapeutic Advances in Childhood Leukemia Consortium Phase 1 2011-09-01 This is a phase I study of the investigational drug AC220 combined with cytarabine and etoposide in pediatric patients with relapsed acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Quizartinib Dihydrochloride

Condition Name

Condition Name for Quizartinib Dihydrochloride
Intervention Trials
Acute Myeloid Leukemia 11
Leukemia, Myeloid, Acute 6
Recurrent Acute Myeloid Leukemia 5
Refractory Acute Myeloid Leukemia 4
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Condition MeSH

Condition MeSH for Quizartinib Dihydrochloride
Intervention Trials
Leukemia, Myeloid, Acute 23
Leukemia 23
Leukemia, Myeloid 22
Myelodysplastic Syndromes 6
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Clinical Trial Locations for Quizartinib Dihydrochloride

Trials by Country

Trials by Country for Quizartinib Dihydrochloride
Location Trials
United States 117
Spain 19
Japan 16
Canada 8
United Kingdom 8
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Trials by US State

Trials by US State for Quizartinib Dihydrochloride
Location Trials
Texas 17
California 8
New York 7
Illinois 6
Pennsylvania 6
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Clinical Trial Progress for Quizartinib Dihydrochloride

Clinical Trial Phase

Clinical Trial Phase for Quizartinib Dihydrochloride
Clinical Trial Phase Trials
Phase 3 3
Phase 2 8
Phase 1/Phase 2 9
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Clinical Trial Status

Clinical Trial Status for Quizartinib Dihydrochloride
Clinical Trial Phase Trials
Completed 14
Recruiting 13
Active, not recruiting 3
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Clinical Trial Sponsors for Quizartinib Dihydrochloride

Sponsor Name

Sponsor Name for Quizartinib Dihydrochloride
Sponsor Trials
Daiichi Sankyo, Inc. 11
Daiichi Sankyo Co., Ltd. 7
Daiichi Sankyo Inc. 7
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Sponsor Type

Sponsor Type for Quizartinib Dihydrochloride
Sponsor Trials
Industry 35
Other 20
NIH 7
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Quizartinib Dihydrochloride: A Breakthrough in Acute Myeloid Leukemia Treatment

Introduction

Quizartinib dihydrochloride, marketed as Vanflyta, has emerged as a significant advancement in the treatment of acute myeloid leukemia (AML), particularly for patients with the FLT3-ITD mutation. Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials: QuANTUM-First and Beyond

QuANTUM-First Trial

The pivotal phase 3 QuANTUM-First trial has been instrumental in establishing quizartinib's efficacy. This randomized, double-blind, placebo-controlled study evaluated quizartinib in combination with standard cytarabine and anthracycline induction and consolidation chemotherapy, followed by quizartinib as maintenance monotherapy in adult patients with newly diagnosed FLT3-ITD positive AML. The trial demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone, with a median overall survival of 31.9 months for patients receiving quizartinib versus 15.1 months for those in the control arm[1][5].

Safety Profile

The safety profile of quizartinib in QuANTUM-First was consistent with previous trials, with no new safety signals observed. Common adverse events included febrile neutropenia, hypokalemia, neutropenia, and pneumonia. QTc prolongation was noted, but it was manageable, and ventricular arrhythmia events were uncommon[1].

Ongoing and Future Studies

Ongoing studies are exploring the use of quizartinib in various settings, including patients with FLT3-ITD-negative AML, those fit or unfit for intensive chemotherapy, and in combination with other compounds like decitabine and venetoclax. Future research aims to optimize the clinical value of quizartinib, better characterize mechanisms of resistance, and investigate its role as maintenance therapy after allogeneic hematopoietic cell transplantation (allo-HCT)[4].

Market Analysis

Current Market Landscape

The approval of quizartinib in July 2023 by the FDA for the treatment of adult patients with newly diagnosed FLT3-ITD positive AML has significantly impacted the AML therapeutics market. This market is driven by the continuous advancement and approval of novel therapies, with quizartinib being a prime example of targeted therapy addressing specific genetic mutations[2].

Market Size and Growth

The AML treatment market is projected to grow from USD 3.47 billion in 2024 to USD 6.29 billion by 2030, with a compound annual growth rate (CAGR) of 10.44%. The myeloblastic leukemia segment, which includes FLT3-ITD positive AML, accounts for the largest market share due to its high incidence and the demand for effective treatments[2].

Competitive Landscape

The market is characterized by a dynamic competitive landscape with pharmaceutical giants, biotechnology innovators, and healthcare institutions vying for market share. Quizartinib, developed by Daiichi Sankyo, is a key player in this landscape, offering a targeted therapy that improves patient outcomes and expands treatment options[2].

Regulatory Approvals and Recommendations

FDA and EMA Approvals

Quizartinib has received significant regulatory approvals. In July 2023, the FDA approved quizartinib for the treatment of adult patients with newly diagnosed FLT3-ITD positive AML. Similarly, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended quizartinib for approval in the EU based on the QuANTUM-First trial results[1][2].

Clinical Implications

These approvals mark a significant milestone in the treatment of FLT3-ITD positive AML, offering patients a new and effective treatment option. Quizartinib is the first FLT3 inhibitor specifically approved for patients with newly diagnosed FLT3-ITD positive AML, highlighting its clinical importance[1].

Future Projections

Expanding Treatment Options

Future research and clinical trials are expected to further optimize the clinical value of quizartinib. This includes exploring its use in additional clinical settings, such as in combination with other therapies and in patients with different disease statuses. The potential for quizartinib to be used as maintenance therapy after allo-HCT is also being investigated[4].

Market Impact

The continued approval and expansion of quizartinib's indications are likely to drive market growth. As more patients benefit from targeted therapies, the demand for such treatments will increase, contributing to the projected growth of the AML treatment market[2].

Key Takeaways

  • Clinical Efficacy: Quizartinib has demonstrated a significant reduction in the risk of death and improved overall survival in patients with newly diagnosed FLT3-ITD positive AML.
  • Safety Profile: The drug's safety profile is manageable, with common adverse events including febrile neutropenia and QTc prolongation.
  • Market Impact: Quizartinib's approval has significantly impacted the AML treatment market, contributing to its projected growth.
  • Future Research: Ongoing and future studies aim to optimize quizartinib's clinical value and explore its use in additional settings.

FAQs

What is quizartinib dihydrochloride used for?

Quizartinib dihydrochloride, marketed as Vanflyta, is used for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.

What were the key findings of the QuANTUM-First trial?

The QuANTUM-First trial showed a 22% reduction in the risk of death and a median overall survival of 31.9 months for patients receiving quizartinib compared to 15.1 months for those in the control arm.

What are the common adverse events associated with quizartinib?

Common adverse events include febrile neutropenia, hypokalemia, neutropenia, and pneumonia. QTc prolongation is also noted but is generally manageable.

How does quizartinib impact the AML treatment market?

Quizartinib's approval has driven market growth by offering a targeted therapy that improves patient outcomes and expands treatment options for AML.

What future research is being conducted on quizartinib?

Future research aims to optimize the clinical value of quizartinib, explore its use in additional clinical settings, and investigate its role as maintenance therapy after allo-HCT.

Sources

  1. Daiichi Sankyo Press Release: Quizartinib Recommended for Approval in EU by CHMP for Patients with Newly Diagnosed FLT3-ITD Positive AML.
  2. Grand View Research: Acute Myeloid Leukemia Treatment Market Size Report, 2030.
  3. Biospace: FDA Decision Tracker.
  4. LARVOL VERI: News - Vanflyta (quizartinib).
  5. FDA: 216993Orig1s000 - accessdata.fda.gov.

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