BREYANZI is a prescription medicine used to treat large B cell lymphoma, a type of non-Hodgkin lymphoma, when:
- your first treatment has not worked or your cancer returned within a year of your first treatment OR...Read more
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See links below for full Prescribing Information, including Boxed WARNINGS and Medication Guide.
*The treatment process includes blood collection, chimeric antigen receptor (CAR) T cell creation, administration, and side-effect monitoring.
Not actual patients or care partner.
Please see full Prescribing Information, including Boxed WARNINGS and
Medication Guide.
Indication
BREYANZI is a prescription medicine used to treat large B cell lymphoma, a type of non-Hodgkin lymphoma, when:
- your first treatment has not worked or your cancer returned within a year of your first treatment OR
- your first treatment has not worked or your cancer returned after the first treatment, and you are not eligible for hematopoietic stem cell transplantation because of medical conditions or age OR
- two or more kinds of treatment have not worked or stopped working.
BREYANZI is different than other cancer medicines because it is made from your own white blood cells, which have been genetically modified to recognize and attack your lymphoma cells.
Important Safety Information
What is the most important information I should know about BREYANZI?
BREYANZI may cause side effects that are life-threatening and can lead to death. Call your healthcare provider or get emergency help right away if you get any of the following:
difficulty breathing
fever (100.4°F/38°C or higher)
chills/shaking chills
confusion
severe nausea, vomiting, diarrhea
fast or irregular heartbeat
dizziness/lightheadedness
severe fatigue or weakness
It is important that you tell your healthcare providers that you have received BREYANZI
and to show them your BREYANZI Patient Wallet Card. Your healthcare provider may
give you other medicines to treat your side effects.
Full Prescribing Information, including Boxed WARNINGS and Medication Guide
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Before getting BREYANZI, tell your healthcare provider about all your medical problems, including if you have or have had:
Neurologic problems
(such as seizures, stroke, or memory loss)Lung or breathing problems
Heart problems
Liver problems
Kidney problems
A recent or active infection
Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive BREYANZI?
BREYANZI is made from your own white blood cells, so your blood will be collected by a process called leukapheresis.
It takes about 3-4 weeks from the time your cells are received at the manufacturing site and are available to be shipped back to your healthcare provider, but the time may vary.
Before you get BREYANZI, you will get 3 days of chemotherapy to prepare your body.
When your BREYANZI is ready, your healthcare provider will give it to you through a catheter placed into your vein. BREYANZI is given as infusions of 2 different cell types.
You will receive infusions of one cell type, immediately followed by the other cell type.
The time for infusion will vary, but will usually be less than 15 minutes for each of the 2 cell types.
During the first week, you will be monitored daily by the facility where you received your treatment.
You should plan to stay close to this location for at least 4 weeks after getting BREYANZI. Your healthcare provider will check to see that your treatment is working and help you with any side effects that may occur.
You may be hospitalized for side effects and your healthcare provider will discharge you if your side effects are under control, and it is safe for you to leave the hospital.
Your healthcare provider will want to do blood tests to follow your progress. It is important that you have your blood tested. If you miss an appointment, call your healthcare provider as soon as possible to reschedule.
What should I avoid after receiving BREYANZI?
Do not drive, operate heavy machinery, or do other activities that could be dangerous if you are not mentally alert, for at least 8 weeks after you get BREYANZI. This is because the treatment can cause temporary memory and coordination problems, including sleepiness, confusion, dizziness, and seizures.
Do not donate blood, organs, tissues, or cells for transplantation.
What are the possible or reasonably likely side effects of BREYANZI?
The most common side effects of BREYANZI are:
fatigue
difficulty breathing
fever (100.4°F/38°C or higher)
chills/shaking chills
confusion
difficulty speaking or slurred speech
severe nausea, vomiting, diarrhea
headache
dizziness/lightheadedness
fast or irregular heartbeat
swelling
BREYANZI can increase the risk of life-threatening infections that may lead to death. Tell your healthcare provider right away if you develop fever, chills, or any signs or symptoms of an infection.
BREYANZI can lower one or more types of your blood cells (red blood cells, white blood cells, or platelets). After treatment, your healthcare provider will test your blood to check for this. Tell your healthcare provider right away if you get a fever, are feeling tired, or have bruising or bleeding.
Having BREYANZI in your blood may cause a false-positive HIV test result by some commercial tests.
These are not all the possible side effects of BREYANZI. Call your doctor for medical advice about side effects. For more information, go to BREYANZI.com or call
1-888-805-4555. You may report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Many people responded to Breyanzi® CAR T cell therapy, even after other treatments did not work or stopped working
Breyanzi has been studied in over 400 people across 3 clinical studies. Select a tab to see the clinical studies that evaluated Breyanzi CAR T cell therapy when used as either a second or later line of treatment.
Study 1: The power for more time without an event
About this study
Who was in this study?
- 184 people with large B-cell lymphoma
- Everyone had previously received 1 line of treatment that either did not work or stopped working within 12 months after the first treatment given
What was the goal of the study?
- To determine the safety and efficacy of Breyanzi compared to standard therapy
What treatment was given?
What treatment was given?
People were randomly put into the following treatment groups:
- Breyanzi CAR T cell therapy
- Standard therapy
During the study, people in standard therapy treatment group were able to receive Breyanzi if:
- They did not respond to standard therapy after 9 weeks
- The cancer progressed at any time
- Another medication was needed
Benefits seen with Breyanzi
more time without an event
An event was defined as cancer getting worse, failing to respond to cancer therapy, or needing to start a new lymphoma treatment.
At the first follow up (6.2-months median), the time without an event was 10.1 months vs 2.3 months (median) with standard therapy.*
*Median is the middle number in a group of numbers arranged from lowest to highest.
3 out of 4 people (68/92) had a complete response at 17.5 months follow-up (median)
Complete response means no signs of cancer were found in the body. Complete response does not mean the cancer has been cured.
Study 2: The power to respond to treatment without stem cell transplant
About this study
Who was in this study?
- 61 people with large B-cell lymphoma who were not able to receive a stem cell transplant
- Everyone had received 1 line of treatment that either did not work stopped working
What was the goal of the study?
- To determine the safety and efficacy of Breyanzi when stem cell transplant is not an option
of people (49/61) responded to Breyanzi54% of people (33/61) achieved a complete response
Complete response means no signs of cancer were found in the body. Complete response does not mean the cancer has been cured.
26% of people (16/61) achieved a partial response
Partial response means the amount of cancer had been reduced.
within 1 month with one-time* Breyanzi
In the clinical study, complete response, or remission, was seen within 1 month (median) after infusion. For some people, this ranged from 0.8 months to 6.9 months.
Remission is a decrease in, or disappearance of, signs and symptoms of cancer.
*The treatment process includes blood collection, CAR T cell creation, administration, and side-effect monitoring.
These are results experienced by people in the Breyanzi clinical trial. Your results may be different.
Most common side effects with Breyanzi
Side effects are possible and should be managed by your healthcare team.
Across all clinical studies, the most common side effects were:
- Fever (100.4°F/38°C or higher)
- Cytokine release syndrome
- Being very tired
- Pain in the muscles and bones
- Nausea
These are not all the common side effects with Breyanzi. Please see more common side effects below in the Important Safety Information.
Call your healthcare provider or get emergency help right away if you have any of the side effects listed above.
It is important that you tell your healthcare providers that you have received Breyanzi and to show them your Breyanzi Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.
Serious side effects
Breyanzi may cause serious side effects that are life-threatening and can lead to death, such as cytokine release syndrome and neurologic toxicity. Your healthcare team is trained to manage the side effects of Breyanzi.
Cytokine release syndrome (CRS)
Cytokine release syndrome, or CRS, happens when the immune cells release a large amount of proteins, called cytokines, into the blood. Some symptoms of CRS include fever, chills, fast heart rate, headache, and not enough oxygen in the tissue.
In the clinical studies, 45% of people (68/150) experienced CRS that was mild to severe
- 1.3% of people experienced severe CRS
- The median time it took for CRS to occur after infusion was 4 days, and the length of time it lasted was a median of 4 days
- CRS generally occurred 1 to 63 days after receiving Breyanzi and lasted 1 to 16 days
Neurologic toxicity
Neurologic toxicity is a serious side effect of the nervous system. It can cause brain disease, involuntary shaking, difficulty speaking, headache, dizziness, and can make it hard to think clearly.
In the clinical studies, 27% of people (41/150) experienced neurologic toxicity that was mild to severe
- 7% of people experienced severe neurologic toxicity
- The median time it took for the first neurologic event to occur after infusion was 8 days, and the length of time it lasted was a median of 6 days
- Neurologic toxicity generally occurred 1 to 63 days after receiving Breyanzi and lasted 1 to 119 days
If you have a fever (100.4ºF/38ºC or higher) or show any other signs or symptoms of CRS or neurologic toxicity, immediately call your healthcare provider, or go to the emergency room as instructed by your healthcare team.
Study 3: The power of a lasting remission
About this study
Who was in this study?
- 192 people with large B-cell lymphoma who have had at least 2 other types of treatment that did not work or stopped working
What was the goal of the study?
- To determine the safety and efficacy of Breyanzi
of people (141/192) responded to Breyanzi54% of people (104/192) achieved a complete response
Complete response means no signs of cancer were found in the body. Complete response does not mean the cancer has been cured.
19% of people (37/192) achieved a partial response
Partial response means the amount of cancer had been reduced.
In a clinical study, half of the people who received Breyanzi were alive
at 2 years after treatment
Overall survival was not a key measurement in this study, and the impact of treatment on survival has not been established. These data included outcomes from 257 people who completed the original study and joined a follow-up study.
These are the results experienced by people in the Breyanzi clinical study. Your results may be different.
Most common side effects with Breyanzi
Side effects are possible and should be managed by your healthcare team.
Across all clinical studies, the most common side effects were:
- Fever (100.4°F/38°C or higher)
- Cytokine release syndrome
- Being very tired
- Pain in the muscles and bones
- Nausea
These are not all the common side effects with Breyanzi. Please see more common side effects below in the Important Safety Information.
Call your healthcare provider or get emergency help right away if you have any of the side effects listed above.
It is important that you tell your healthcare providers that you have received Breyanzi and to show them your Breyanzi Patient Wallet Card. Your healthcare provider may give you other medicines to treat your side effects.
Serious side effects
Breyanzi may cause serious side effects that are life-threatening and can lead to death, such as cytokine release syndrome and neurologic toxicity. Your healthcare team is trained to manage the side effects of Breyanzi.
Cytokine release syndrome (CRS)
Cytokine release syndrome, or CRS, happens when the immune cells release a large amount of proteins, called cytokines, into the blood. Some symptoms of CRS include fever, chills, fast heart rate, headache, and not enough oxygen in the tissue.
In the clinical study, 46% of people (122/268) experienced CRS toxicity that was mild to life-threatening or fatal
- 4% of people experienced severe to fatal CRS. One person had fatal CRS and 2 had ongoing CRS at time of death
- The median time it took for CRS to occur after infusion was 5 days, and the length of time it lasted was a median of 5 days
- CRS generally occurred 1 to 15 days after receiving Breyanzi and lasted 1 to 17 days
Neurologic toxicity
Neurologic toxicity is a serious side effect of the nervous system. It may cause a condition that could change how the brain works or its structure, as well as shaking that you cannot control, difficulty speaking, headache, dizziness, and can also make it harder to think clearly. These are not all of the signs and symptoms. Call your healthcare team immediately if you notice any changes.
In the clinical study, 35% of people (96/268) experienced neurologic toxicity that was mild to life-threatening or fatal
- 12% of people experienced severe neurologic toxicity. Three people had fatal neurologic toxicity and 7 had ongoing neurologic toxicity at time of death
- The median time it took for the first neurologic event to occur after infusion was 8 days, and the length of time it lasted was a median of 12 days
- Neurologic toxicity generally occurred 1 to 46 days after receiving Breyanzi and lasted 1 to 87 days
If you have a fever (100.4ºF/38ºC or higher) or show any other signs or symptoms of CRS or neurologic toxicity, immediately call your healthcare provider, or go to the emergency room as instructed by your healthcare team.