How was KOMZIFTI evaluated in a clinical study?
The median age was 69 years (range: 22-86 years). 38% of patients were <65 years of age. 63% of patients were ≥65 years of age.
The primary goal (or primary endpoint) of the study was to see how many patients who received KOMZIFTI achieved complete remission (CR) or complete remission with partial hematologic recovery (CRh).
Complete remission
No signs of leukemia and blood counts returned to normal
Complete remission with partial hematologic recovery
No signs of leukemia, but some blood counts did not return to normal
The study also looked at other important outcomes, including how long it took for the treatment to start working and whether patients needed blood transfusions, as well as drug safety and tolerability.
months
(range: 0.9-15.0 months)
The median time to first response was 2.7 months in patients who achieved CR or CRh.
Your doctor may want to keep you on KOMZIFTI to give it time to work.
21% of patients
(14/66) who needed transfusions at the start
of the study achieved transfusion independence during any 56-day period after the start of the study.
26% of patients
(12/46) who didn't need transfusions at the start of the study remained transfusion independent during any 56-day period after the start of the study.
Treatment affects each person differently. If you think you’re experiencing a side effect from your treatment, reach out to your doctor right away.
Differentiation syndrome is a serious condition that affects your blood cells and can be life-threatening or lead to death if not treated. Differentiation syndrome can happen as early as 3 days after you start KOMZIFTI treatment and can also happen later during treatment with KOMZIFTI.
Tell your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following signs or symptoms of differentiation syndrome during treatment with KOMZIFTI:
If you develop signs and symptoms of differentiation syndrome during treatment with KOMZIFTI, your healthcare provider may temporarily stop KOMZIFTI and give you a corticosteroid medicine.
Your healthcare provider will monitor you until your signs and symptoms improve.
KOMZIFTI can cause serious side effects, including QT prolongation
Changes in the electrical activity of your heart (QT prolongation) may lead to irregular heartbeats (rhythm) 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 KOMZIFTI. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy, or if you have shortness of breath, or if you feel your heart beating irregularly or fast during treatment with KOMZIFTI.
Before taking KOMZIFTI, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about any other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KOMZIFTI and other medicines may affect each other, causing side effects.
Your healthcare provider may decrease your dose, temporarily stop, or completely stop your treatment with KOMZIFTI if you develop certain side effects during treatment with KOMZIFTI.
KOMZIFTI may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of KOMZIFTI. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
KOMZIFTI is a prescription medicine used to treat adults with acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation whose AML has come back or did not improve after previous treatment(s) and who have no other satisfactory treatment options.
Your healthcare provider will perform a test to make sure that KOMZIFTI is right for you.
It is not known if KOMZIFTI is safe and effective in children.
Please see full Prescribing Information, including Boxed WARNING, and Medication Guide for additional information.
What is the most important information I should know about KOMZIFTI?
KOMZIFTI can cause serious side effects including:Differentiation Syndrome: Differentiation syndrome is a condition that affects your blood cells that is common during treatment with KOMZIFTI and can be life-threatening or lead to death if not treated. Differentiation syndrome can happen as early as 3 days after you start KOMZIFTI treatment and can also happen later during treatment with KOMZIFTI. Tell your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following signs or symptoms of differentiation syndrome during treatment with KOMZIFTI:
If you develop signs and symptoms of differentiation syndrome during treatment with KOMZIFTI, your healthcare provider may temporarily stop KOMZIFTI and give you a corticosteroid medicine. Your healthcare provider will monitor you until your signs and symptoms improve.
Changes in electrical activity of your heart (QT prolongation).
Changes in the electrical activity of your heart may lead to irregular heartbeats (rhythm) 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 KOMZIFTI. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy, or if you have shortness of breath, or if you feel your heart beating irregularly or fast during treatment with KOMZIFTI.
Before taking KOMZIFTI, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about any other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
KOMZIFTI and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.
The most common side effects of KOMZIFTI include:
Your healthcare provider may decrease your dose, temporarily stop, or completely stop your treatment with KOMZIFTI if you develop certain side effects during treatment with KOMZIFTI.
KOMZIFTI may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all the possible side effects of KOMZIFTI. Call your doctor for medical advice about side effects.
You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNING, and Medication Guide for additional information.
KOMZIFTI is a prescription medicine used to treat adults with acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation whose AML has come back or did not improve after previous treatment(s) and who have no other satisfactory treatment options.
Your healthcare provider will perform a test to make sure that KOMZIFTI is right for you.
It is not known if KOMZIFTI is safe and effective in children.
Please see full Prescribing Information, including Boxed WARNING, and Medication Guide for additional information.
What is the most important information I should know about KOMZIFTI?
KOMZIFTI can cause serious side effects including:Differentiation Syndrome: Differentiation syndrome is a condition that affects your blood cells that is common during treatment with KOMZIFTI and can be life-threatening or lead to death if not treated. Differentiation syndrome can happen as early as 3 days after you start KOMZIFTI treatment and can also happen later during treatment with KOMZIFTI. Tell your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following signs or symptoms of differentiation syndrome during treatment with KOMZIFTI:
If you develop signs and symptoms of differentiation syndrome during treatment with KOMZIFTI, your healthcare provider may temporarily stop KOMZIFTI and give you a corticosteroid medicine. Your healthcare provider will monitor you until your signs and symptoms improve.
Changes in electrical activity of your heart (QT prolongation).
Changes in the electrical activity of your heart may lead to irregular heartbeats (rhythm) 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 KOMZIFTI. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy, or if you have shortness of breath, or if you feel your heart beating irregularly or fast during treatment with KOMZIFTI.
Before taking KOMZIFTI, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about any other medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
KOMZIFTI and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.
The most common side effects of KOMZIFTI include:
Your healthcare provider may decrease your dose, temporarily stop, or completely stop your treatment with KOMZIFTI if you develop certain side effects during treatment with KOMZIFTI.
KOMZIFTI may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all the possible side effects of KOMZIFTI. Call your doctor for medical advice about side effects.
You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNING, and Medication Guide for additional information.