BREYANZI is a prescription medicine used to treat a type of non-Hodgkin lymphoma:
- Large B cell lymphoma, when:
- your first treatment has not worked or your cancer returned within a year of your first treatment, OR...Read more
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
DOWNLOAD
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.
There were 3 clinical studies for Breyanzi that included a wide range of people
In these clinical studies, over 400 people were treated with Breyanzi. Patients included those who had received a stem cell transplant as well as those who were not eligible.
Select a tab to see the clinical studies that evaluated Breyanzi CAR T cell therapy when used as either a second line or later line of treatment.
AFTER A 1TIME* INFUSION
Ongoing treatment for large B-cell lymphoma is not needed
while you are responding to Breyanzi.
- NO ongoing infusions
- NO maintenance treatments
- NO daily pills
Regular checkups with your healthcare team will be needed so they can keep track of how well you are doing and check to see if other medications are needed to manage side effects.
Some patients treated with Breyanzi may develop other cancers. Your healthcare team will provide lifelong monitoring for these cancers.
*The treatment process includes blood collection, CAR T cell creation, administration, and side-effect monitoring.
Study 1: Complete remission is possible, even if another treatment didn’t work
Who took part in the study?
The study was comprised of 184 people with LBCL who had 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 was seen?
In a clinical study, people treated with Breyanzi went 4x longer without an event than those treated with standard therapy at 6.2 months follow-up (median). At the first follow-up, the time without an event was 10.1 months vs 2.3 months (median) with standard therapy. An event was the cancer getting worse, failing to respond to cancer therapy, or needing to start a new lymphoma treatment.
At 33.9 months follow-up (median)
3 OUT
OF 4
people (68/92) treated with Breyanzi had no signs of LBCL
In comparison to less than 2 out of 4 (40/92) of people who were treated with standard therapy.
This is called complete response. It does not mean the cancer has been cured.
Study 2: Remission is possible in people who cannot undergo a stem cell transplant
Who took part in the study?
The study was comprised of 61 people with LBCL who were not able to receive a stem cell transplant and who had received 1 line of treatment that either did not work or 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.
What was seen?
80%
of people (49/61) responded to Breyanzi
This is called overall response. It measures a decrease or disappearance of cancer in the body.
Of those treated with Breyanzi, 54% of people (33/61) saw no signs of lymphoma (called complete response) and the rest of the people who responded (16/61) had a partial response, which means that the amount of cancer in their body had been reduced.
A complete response does not mean the cancer has been cured.
Remission was achieved within 1 month with 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.
These are the results experienced by people in the Breyanzi clinical study.
Your results may be different.
Study 3: Complete remission is possible after 2 or more treatments
Who took part in the study?
The study was comprised of 192 people with large B-cell lymphoma who had received at least 2 other types of treatment, including some who had received a prior stem cell transplant, that did not work or stopped working.
What was the goal of the study?
To determine the safety and efficacy of Breyanzi.
What was seen?
73%
of people (141/192) responded to Breyanzi
This is called overall response. It measures a decrease or disappearance of cancer in the body.
Of those treated with Breyanzi, 54% of people (104/192) had no signs of lymphoma (called complete response) and the rest of the people who responded (37/192) had a partial response, which means that the amount of cancer in their body had been reduced.
Complete response does not mean the cancer has been cured.
These are the results experienced by people in the Breyanzi clinical study. Your results may be different.
Side effects are possible
Side effects are possible. Your healthcare team knows what to look for with Breyanzi and is prepared to manage any side effects that may occur.
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
- low blood pressure
- muscle pain
These are not all the possible side effects of Breyanzi. See possible serious side effects below.
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 have any of the side effects listed above or below. For medical emergencies, call 911.
Possible serious side effects to know about
Breyanzi may cause serious side effects that are life-threatening and can lead to death. Your healthcare team is trained to manage the side effects of Breyanzi, such as cytokine release syndrome (CRS) and neurologic toxicity (NT).
Cytokine release syndrome
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 getting into the tissues of the body.
When did CRS happen and how long
did it last in clinical studies of Breyanzi?
Most likely* to
happen around
after infusion
Range: 1-63 days
Most likely* to
improve around
after onset
Range: 1-37 days
- The Breyanzi clinical studies included a total of 702 people, 54% of them experienced CRS
- 51% of people had mild to moderate CRS
- 3.2% of people experienced severe CRS
If you have a fever (100.4ºF/38ºC or higher) or show any other signs or symptoms of CRS, immediately call your healthcare provider, or go to the emergency room as instructed by your healthcare team.
You will need to stay near the treatment center for at least 4 weeks to be monitored for side effects.
*Based on median days from the clinical studies.
Neurologic toxicity
Neurologic toxicity, or NT, is a serious side effect that can cause damage to the nervous system. It can cause brain disease, shaking, difficulty speaking, and headache and can make it hard to think clearly.
When did NT happen and how long did it last
in clinical studies of Breyanzi?
Most likely* to
happen around
after infusion
Range: 1-63 days
Most likely* to
improve around
after onset
Range: 1-119 days
- The Breyanzi clinical studies included a total of 702 people, 31% of them experienced neurologic toxicity
- 21% of people experienced mild to moderate NT
- 10% of people experienced severe NT
If you have a fever (100.4ºf/38ºC or higher) or show any other signs or symptoms of NT, call your healthcare provider or go to the emergency room as instructed by your healthcare team.
You will need to stay near the treatment center for at least 4 weeks to be monitored for side effects.
*Based on median days from the clinical studies.