Prescription medicine
Quizartinib Brand names: Vanflyta
Quizartinib (Vanflyta) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the quizartinib FDA label on DailyMed (effective April 16, 2026, Daiichi Sankyo Inc.); the NDA 216993 record on Drugs@FDA; every quizartinib label on DailyMed.
Highlights of the record
FDA label of April 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
QT PROLONGATION, TORSADES DE POINTES,.
and CARDIAC ARREST VANFLYTA prolongs the QT interval in a dose- and concentration-related manner [see Clinical Pharmacology (12.2) ]. Prior to VANFLYTA administration and periodically, monitor for hypokalemia or hypomagnesemia, and correct deficiencies. Perform ECGs to monitor the QTc at baseline, weekly during induction and consolidation therapy, weekly for at least the first month of maintenance, and periodically thereafter [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. Torsades de pointes and cardiac arrest have occurred in patients receiving VANFLYTA. Do not administer VANFLYTA to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome [see Contraindications (4) and Warnings and Precautions (5.1) ]. Do not initiate treatment with VANFLYTA or escalate the VANFLYTA dose if the QT interval corrected by Fridericia's formula (QTcF) is greater than 450 ms [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. Monitor ECGs more frequently if concomitant use of drugs known to prolong the QT interval is required [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. Reduce the VANFLYTA dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure [see Dosage and Administration (2.4) and Warnings and Precautions (5.1) ]. […]
Used for
From the label: indications and usageVANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Stu
Forms and strengths
- 17.7 mg
- 26.5 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 20, 2023 Vanflyta, Daiichi Sankyo Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 30, 2033 Vanflyta tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 634 through July 30, 2026
What is quizartinib used for?
From the label: indications and usageVANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14) ]. […]
Conditions named in the indications of quizartinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (VANFLYTA), Daiichi Sankyo Inc., effective April 16, 2026 (SPL set 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86), via openFDA; the full label on DailyMed
What does the patient leaflet for quizartinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VANFLYTA?VANFLYTA may cause serious side effects, including: Changes in the electrical activity of your heart called QT prolongation, torsades de pointes, and your heart stopping (cardiac arrest). QT prolongation can cause irregular heartbeats that can be life-threatening or lead to death. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and will also do blood tests to check your potassium and magnesium levels before and during treatment with VANFLYTA. Tell your healthcare provider right away if you have an irregular heartbeat or feel dizzy, lightheaded, or faint, or have diarrhea or vomiting. VANFLYTA is available only through a restricted program called the VANFLYTA Risk Evaluation and Mitigation Strategy (REMS) due to the risk of QT prolongation, torsades de pointes, and cardiac arrest. You will receive a VANFLYTA Patient Wallet Card from your healthcare provider. Carry the VANFLYTA Patient Wallet Card with you at all times and show it to all of your healthcare providers. The VANFLYTA Patient Wallet Card lists signs and symptoms of QT prolongation and torsades de pointes. Get medical help right away if you develop any of the signs and symptoms listed on the VANFLYTA Patient Wallet Card. You may need to be treated in a hospital. See " What are the possible side effects of VANFLYTA? " for more information about side effects.
From the patient leaflet: How should I store VANFLYTA?Store VANFLYTA at room temperature between 68°F and 77°F (20°C and 25°C). Keep VANFLYTA and all medicines out of the reach of children.
Source: FDA drug label (VANFLYTA), Daiichi Sankyo Inc., effective April 16, 2026 (SPL set 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86), via openFDA; the full label on DailyMed
Is there a generic for quizartinib (Vanflyta)?
No generic quizartinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 11 patents for Vanflyta tablets: the compound patent runs to September 26, 2028, and the last listed entry to September 30, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the quizartinib label say about other medicines?
The quizartinib label names 8 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atovaquone | drug interactions | … limited to antifungal azoles, ondansetron, granisetron, azithromycin, pentamidine, doxycycline, moxifloxacin, atovaquone, prochlorperazine, and tacrolimus. |
| Azithromycin | drug interactions | … Examples of QT prolonging drugs include but are not limited to antifungal azoles, ondansetron, granisetron, azithromycin, pentamidine, doxycycline, moxifloxacin, atovaquone, prochlorperazine, and tacrolimus. |
| Doxycycline | drug interactions | … drugs include but are not limited to antifungal azoles, ondansetron, granisetron, azithromycin, pentamidine, doxycycline, moxifloxacin, atovaquone, prochlorperazine, and tacrolimus. |
| Granisetron | drug interactions | … is required. Examples of QT prolonging drugs include but are not limited to antifungal azoles, ondansetron, granisetron, azithromycin, pentamidine, doxycycline, moxifloxacin, atovaquone, prochlorperazine, and tacrolimus. |
| Moxifloxacin | drug interactions | … but are not limited to antifungal azoles, ondansetron, granisetron, azithromycin, pentamidine, doxycycline, moxifloxacin, atovaquone, prochlorperazine, and tacrolimus. |
| Ondansetron | drug interactions | … QT interval is required. Examples of QT prolonging drugs include but are not limited to antifungal azoles, ondansetron, granisetron, azithromycin, pentamidine, doxycycline, moxifloxacin, atovaquone, prochlorperazine, and tacrolimus. |
| Prochlorperazine | drug interactions | … antifungal azoles, ondansetron, granisetron, azithromycin, pentamidine, doxycycline, moxifloxacin, atovaquone, prochlorperazine, and tacrolimus. |
| Tacrolimus | drug interactions | … ondansetron, granisetron, azithromycin, pentamidine, doxycycline, moxifloxacin, atovaquone, prochlorperazine, and tacrolimus. |
Source: FDA drug label (VANFLYTA), Daiichi Sankyo Inc., effective April 16, 2026 (SPL set 29cdbcfe-497d-4e78-bb7b-2d4acafe8e86), via openFDA; the full label on DailyMed
What do FAERS reports show for quizartinib?
The FDA Adverse Event Reporting System holds 634 reports that list quizartinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 100 are coded as a death and 217 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as quizartinib?
37 other medicines are given the same way (oral) and in the same FDA class as quizartinib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Bosutinib | Leukemia, lymphoma and myeloma | 3 labelers | n/a | No current entry |
| Ibrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Ponatinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Acalabrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Pirtobrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as quizartinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to quizartinib
- 37 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Quizartinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other