Vanflyta (quizartinib)
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Quizartinib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Quizartinib
- Brand name
- Vanflyta
- Development code
- AC220
- Drug class
- Kinase inhibitor (FLT3, type II)
- Manufacturer
- Daiichi Sankyo
- How it's taken
- Oral tablet once daily, with chemotherapy and then as maintenance
A once-daily pill added to standard induction and consolidation chemotherapy, then continued alone as maintenance for up to 3 years, for adults with newly diagnosed AML that carries a FLT3 internal tandem duplication (FLT3-ITD). Approved July 20, 2023 with a boxed warning for heart rhythm effects and a restricted distribution program.
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Where Quizartinib fits
The second FLT3 inhibitor approved with induction chemotherapy, after Rydapt. Vanflyta is limited to FLT3-ITD but includes a maintenance phase; Rydapt covers ITD and TKD mutations and stops after consolidation. No trial has compared them directly.
How Quizartinib works
Quizartinib and its active metabolite bind the ATP pocket of the FLT3 receptor and stop it from signaling, which blocks the growth drive created by a FLT3-ITD mutation[1]. It is a type II inhibitor: it binds the inactive form of FLT3, which makes it potent against the ITD form but not against TKD point mutations such as D835, which is why the label is limited to FLT3-ITD disease[1].
Mechanism: Oral type II FLT3 inhibitor that is highly selective for FLT3-ITD
Side effects and safety
- QT prolongation. Do not start if QTcF is above 450 msec; avoid other QT-prolonging drugs where possible; strong CYP3A inhibitors require a lower dose.
- Embryo-fetal toxicity. Can harm an unborn baby; contraception during treatment and for 7 months after (women) or 4 months after (men).
- ECG before starting, weekly during induction and consolidation, weekly for at least the first month of maintenance, then periodically
- Potassium and magnesium before and during treatment
- Blood counts with the chemotherapy schedule
- Pregnancy test before starting
Vanflyta carries a boxed warning for QT prolongation, torsades de pointes and cardiac arrest. It prolongs the QT interval in a dose-related way, so ECGs are done before starting, weekly during induction and consolidation, weekly for the first month of maintenance and then periodically, potassium and magnesium are kept normal, and it is available only through the Vanflyta REMS program[1].
The other warning is harm to an unborn baby[1]. In QuANTUM-First the side effects at least 2 percentage points more common with quizartinib than placebo included low lymphocytes, potassium, albumin, phosphorus and magnesium, febrile neutropenia, diarrhea, mouth sores, nausea, sepsis, neutropenia, headache, vomiting, upper respiratory and fungal infections, nosebleeds, raised liver enzymes and low platelets[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Quizartinib
Vanflyta tablets are taken by mouth once a day with or without food. A course is up to 2 cycles with induction cytarabine and an anthracycline (starting on day 8 of a 7+3 cycle), up to 4 cycles with high-dose cytarabine consolidation, and then up to 36 cycles (about 3 years) of maintenance alone, starting after blood counts recover following consolidation[1].
The induction and consolidation dose is 35.4 mg daily; maintenance starts at 26.5 mg and rises to 53 mg if the QTcF stays 450 msec or less; doses are halved with strong CYP3A inhibitors[1]. It is not given as maintenance after an allogeneic transplant, because a survival benefit was not shown in that group[1].
Availability and cost
Only available as the brand-name product.
Help paying for Vanflyta
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Free medicine program
AccessCentral4U provides Daiichi Sankyo products, including Vanflyta, at no cost to eligible uninsured or underinsured patients.
For: no insurance, underinsured · source - Insurance and case manager help
Medication coverage and access support and financial assistance information through www.DSAccessCentral4U.com.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: The Daiichi Sankyo patient assistance page gives no phone number or copay terms, and vanflyta.com did not load during this check. A copay program is not listed here until it is confirmed on a Daiichi Sankyo page.
Access and eligibility
Adults with newly diagnosed AML that is FLT3-ITD positive by an FDA-approved test, treated with standard cytarabine and anthracycline induction. It does not cover FLT3-TKD mutations, relapsed AML, or maintenance after an allogeneic stem cell transplant.
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
How the targeted AML pills compare, by mutation
AML has 19 FDA-approved medicines, counting the 3 older chemotherapy drugs. This chart covers the 8 that target a specific gene change, because the result of your mutation test decides which of them could apply to you. Chemotherapy (7+3, Vyxeos), Venclexta, Mylotarg, Onureg, Daurismo and the APL drugs are described on the drug pages instead. Several of these drugs are only approved after relapse, and all of the FLT3, IDH and menin drugs can cause differentiation syndrome, so your leukemia doctor will weigh the mutation, your point in treatment and your heart and liver tests.
Acute Myeloid Leukemia has 8 FDA-approved treatments: Rydapt (midostaurin, approved 2017); Vanflyta (quizartinib, approved 2023); Xospata (gilteritinib, approved 2018); Tibsovo (ivosidenib, approved 2018); Rezlidhia (olutasidenib, approved 2022); Idhifa (enasidenib, approved 2017); Revuforj (revumenib, approved 2024); Komzifti (ziftomenib, approved 2025). Rydapt is typically used as newly diagnosed, with intensive chemotherapy.
| Drug | Mutation it targets | When it is approved | How it's taken | How often | Given with | FDA approved |
|---|---|---|---|---|---|---|
Rydapt midostaurin | FLT3 (ITD or TKD) | Newly diagnosed, with intensive chemotherapy | Oral capsule | Twice daily on days 8 to 21 of each chemotherapy cycle | 7+3 induction and high-dose cytarabine consolidation (hospital-based chemotherapy) | 2017 |
Vanflyta quizartinib You are here | FLT3-ITD only | Newly diagnosed, with intensive chemotherapy, then maintenance | Oral tablet | Once daily, with chemotherapy and then up to 36 months of maintenance | 7+3 induction and cytarabine consolidation, then alone as maintenance (not after transplant) | 2023 |
Xospata gilteritinib | FLT3 (ITD or TKD) | Relapsed or refractory | Oral tablets | Once daily | Taken alone | 2018 |
Tibsovo ivosidenib | IDH1 | Newly diagnosed (older or unfit) and relapsed or refractory | Oral tablets | Once daily | With azacitidine or alone (newly diagnosed, 75+ or unfit); alone at relapse | 2018 |
Rezlidhia olutasidenib | IDH1 | Relapsed or refractory | Oral capsule | Twice daily on an empty stomach | Taken alone | 2022 |
Idhifa enasidenib | IDH2 | Relapsed or refractory | Oral tablet | Once daily | Taken alone | 2017 |
Revuforj revumenib | KMT2A rearrangement (any acute leukemia) or NPM1 mutation (AML) | Relapsed or refractory (NPM1: after other options) | Oral tablets | Twice daily | Taken alone; adults and children 1 year and older | 2024 |
Komzifti ziftomenib | NPM1 mutation | Relapsed or refractory, after other options | Oral capsules | Once daily on an empty stomach | Taken alone; adults only | 2025 |
This chart is for education only and is not medical advice. Approval dates, indications and warnings come from each drug's FDA prescribing information and Drugs@FDA. None of these drugs has been compared head to head with another in the same column, and trial results are not comparable across different studies. A leukemia specialist who has your mutation report will know which, if any, applies to you and whether a clinical trial would fit better.
Clinical trial results
QuANTUM-First (NCT02668653) randomized 539 adults aged 18 to 75 with newly diagnosed FLT3-ITD AML to quizartinib or placebo with 7+3 induction, high-dose cytarabine consolidation and then up to 3 years of maintenance. After at least 24 months of follow-up, overall survival was better with quizartinib (hazard ratio 0.78, 95% CI 0.62 to 0.98, p=0.0324).
Complete remission rates were 55% in both arms, but remissions lasted longer with quizartinib (median 38.6 months against 12.4 months)[1][2]. In the 43% of patients who received maintenance without a transplant the survival hazard ratio was 0.40, while in the 57% who had a transplant first it was 1.62 with a wide confidence interval, which is why the label excludes post-transplant maintenance[1].
Development history
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Common questions about Quizartinib
▸What is Quizartinib (Vanflyta)?
A once-daily pill added to standard induction and consolidation chemotherapy, then continued alone as maintenance for up to 3 years, for adults with newly diagnosed AML that carries a FLT3 internal tandem duplication (FLT3-ITD). Approved July 20, 2023 with a boxed warning for heart rhythm effects and a restricted distribution program.
▸How does Quizartinib work?
Quizartinib and its active metabolite bind the ATP pocket of the FLT3 receptor and stop it from signaling, which blocks the growth drive created by a FLT3-ITD mutation[1]. It is a type II inhibitor: it binds the inactive form of FLT3, which makes it potent against the ITD form but not against TKD point mutations such as D835, which is why the label is limited to FLT3-ITD disease[1].
▸What are the side effects of Quizartinib?
Vanflyta carries a boxed warning for QT prolongation, torsades de pointes and cardiac arrest. It prolongs the QT interval in a dose-related way, so ECGs are done before starting, weekly during induction and consolidation, weekly for the first month of maintenance and then periodically, potassium and magnesium are kept normal, and it is available only through the Vanflyta REMS program[1]. The other warning is harm to an unborn baby[1]. In QuANTUM-First the side effects at least 2 percentage points more common with quizartinib than placebo included low lymphocytes, potassium, albumin, phosphorus and magnesium, febrile neutropenia, diarrhea, mouth sores, nausea, sepsis, neutropenia, headache, vomiting, upper respiratory and fungal infections, nosebleeds, raised liver enzymes and low platelets[1].
▸How is Quizartinib taken?
Vanflyta tablets are taken by mouth once a day with or without food. A course is up to 2 cycles with induction cytarabine and an anthracycline (starting on day 8 of a 7+3 cycle), up to 4 cycles with high-dose cytarabine consolidation, and then up to 36 cycles (about 3 years) of maintenance alone, starting after blood counts recover following consolidation[1]. The induction and consolidation dose is 35.4 mg daily; maintenance starts at 26.5 mg and rises to 53 mg if the QTcF stays 450 msec or less; doses are halved with strong CYP3A inhibitors[1]. It is not given as maintenance after an allogeneic transplant, because a survival benefit was not shown in that group[1].
▸Is Quizartinib FDA approved?
Yes, Quizartinib (Vanflyta) is FDA approved (2023) for the treatment of Acute Myeloid Leukemia.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Daiichi Sankyo via openFDA · 2026-04-16. Vanflyta (quizartinib) tablets prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%2229cdbcfe-497d-4e78-bb7b-2d4acafe8e86%22
- The Lancet · 2023-05-13. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First). https://pubmed.ncbi.nlm.nih.gov/37116523/
- FDA. Vanflyta approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216993
- Daiichi Sankyo, Inc.. Patient Assistance Programs: AccessCentral4U. https://daiichisankyo.us/patient-assistance-programs