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Breyanzi is not approved for pediatric use
Advancing Hopein the
Fight Against Cancer
How a pioneering personalized therapy can change medical outcomes for patients with certain relapsed or refractory B-cell lymphomas
Astrid
It started with itching all over her body. Astrid, a graduate student working to become a physician assistant, grew easily winded while exercising and couldn’t lie down without upper back pain. Excruciating chest pain hit, prompting a visit to the emergency room, where doctors found a hidden, massive tumor within her 5 foot 1 inch frame. “It was essentially compressing my heart against my back,” she says.
The 29-year-old Houstonite had a rare, fast-growing subtype of large B-cell lymphoma (LBCL), a blood cancer that’s typically diagnosed in patients 65 and older, and started standard chemotherapy to fight it. By her fourth round of treatment, she developed painful blisters on her tongue. “I couldn’t drink, I couldn’t eat, I couldn’t speak,” she recalls. Despite these side effects, Astrid soldiered through a total of six rounds. Two months later, after the familiar itching returned, a scan confirmed the cancer was back.
Enter CAR T cell therapy, which Astrid's doctor called "the big guns." CAR T cell therapy is different from other cancer medicines, the doctor said, because your own white blood cells are genetically modified to recognize and attack the lymphoma cells. After discussing all the risks and benefits of different treatment options, Astrid received a CAR T cell therapy, Breyanzi® (lisocabtagene maraleucel), which is approved to treat adults with relapsed or refractory large B cell lymphoma, a type of non-Hodgkin lymphoma.
Though he was not Astrid’s doctor, Dr. Matthew Lunning, associate professor at the University of Nebraska Medical Center, treats many patients with LBCL and has seen firsthand how effective the treatment can be. He notes that "CAR T treatment may not be for everyone, but I certainly believe it should be the initial part of the discussion. It’s imperative to balance the risks and benefits of Breyanzi. Patients should talk with their care team about the process and potential life-threatening or fatal side effects like cytokine release syndrome (CRS), increased risk of life-threatening infections, lowering of one or more types of your blood cells, neurologic toxicity, secondary malignancies, and common side effects like fatigue, fever, muscle pain, severe nausea, vomiting, diarrhea and headache. Understanding the full picture helps patients make choices that are right for them.”
Please see full safety information about Breyanzi below.
The treatment process for Breyanzi begins with a complex type of blood draw that separates T cells, a type of white blood cell that functions as a key fighter in the immune system, from other blood components.
The T cells are then sent to a specialized facility where they are genetically reprogrammed to become CAR T cells by adding tiny hooks, called chimeric antigen receptors (CAR), to their surfaces. The lab then reproduces millions of these CAR T cells to create the recommended dose of Breyanzi.
After rigorous testing and quality control, the reprogrammed CAR T cells can be infused back into the patient as their cancer-fighting therapy. Afterward, the modified cells have the potential to better recognize and attack the target cells, even types that have evaded the body’s original immune fighters. Although Breyanzi requires only a single infusion, all told, the entire process, including initial monitoring following treatment, takes two to three months.
Upward of 40 percent of LBCL patients are refractory or relapsed, meaning their cancers don’t respond to initial treatment or have come back, and in general, blood cancer patients often experience significant unmet needs after cycles of first-line therapy. In a Breyanzi study that evaluated 61 patients with second-line relapsed or refractory LBCL who were not eligible for stem cell transplant, 80 percent experienced a decrease or disappearance of their cancer, called an overall response. Of this group, 54 percent of people saw no signs of lymphoma, called a complete response or remission, and the other 26 percent had partial responses, a reduction in the amount of cancer. In some cases, remission was achieved within one month of treatment. Patients then continued regular check-ins with their health care team to monitor for and manage potential side effects.
After months of attempting prior therapies without progress, Astrid’s tumor started to shrink four weeks after her Breyanzi infusion. Her doctor explained that the CAR T cells were working and would continue to do so for the next few months. Eager to move on, Astrid powered through side effects, passed her professional certification exam and began applying for jobs — all while hoping for clear scans.
A few months after her infusion, she received the news she hoped to hear: She was in remission.
Looking back, despite the many hardships, her family of three (soon to be four!), has more than enough to celebrate.
“I thought I was going to die,” Astrid says, choking up. “Breyanzi gave me hope for the future.”
Please see Important Safety Information below and full Prescribing Information, including Boxed WARNINGS and Medication Guide.
It is important to note that there is no available data with the use of Breyanzi during or after pregnancy and it is not known if Breyanzi passes to the fetus, therefore it is not recommended for women who are pregnant. Pregnancy after Breyanzi infusion should be discussed with the treating physician.
Scroll to Continue
Breyanzi is not approved for pediatric use
Advancing Hopein the
Fight Against Cancer
How a pioneering personalized therapy can change medical outcomes for patients with certain relapsed or refractory B-cell lymphomas
Astrid
It started with itching all over her body. Astrid, a graduate student working to become a physician assistant, grew easily winded while exercising and couldn’t lie down without upper back pain. Excruciating chest pain hit, prompting a visit to the emergency room, where doctors found a hidden, massive tumor within her 5 foot 1 inch frame. “It was essentially compressing my heart against my back,” she says.
The 29-year-old Houstonite had a rare, fast-growing subtype of large B-cell lymphoma (LBCL), a blood cancer that’s typically diagnosed in patients 65 and older, and started standard chemotherapy to fight it. By her fourth round of treatment, she developed painful blisters on her tongue. “I couldn’t drink, I couldn’t eat, I couldn’t speak,” she recalls. Despite these side effects, Astrid soldiered through a total of six rounds. Two months later, after the familiar itching returned, a scan confirmed the cancer was back.
Enter CAR T cell therapy, which Astrid's doctor called "the big guns." CAR T cell therapy is different from other cancer medicines, the doctor said, because your own white blood cells are genetically modified to recognize and attack the lymphoma cells. After discussing all the risks and benefits of different treatment options, Astrid received a CAR T cell therapy, Breyanzi® (lisocabtagene maraleucel), which is approved to treat adults with relapsed or refractory large B-cell lymphoma, a type of non-Hodgkin lymphoma.
Though he was not Astrid’s doctor, Dr. Matthew Lunning, associate professor at the University of Nebraska Medical Center, treats many patients with LBCL and has seen firsthand how effective the treatment can be. He notes that "CAR T treatment may not be for everyone, but I certainly believe it should be the initial part of the discussion. It’s imperative to balance the risks and benefits of Breyanzi. Patients should talk with their care team about the process and potential life-threatening or fatal side effects like cytokine release syndrome (CRS), increased risk of life-threatening infections, lowering of one or more types of your blood cells, neurologic toxicity, secondary malignancies, and common side effects like fatigue, fever, muscle pain, severe nausea, vomiting, diarrhea and headache. Understanding the full picture helps patients make choices that are right for them.”
Please see full safety information about Breyanzi below.
The treatment process for Breyanzi begins with a complex type of blood draw that separates T cells, a type of white blood cell that functions as a key fighter in the immune system, from other blood components.
The T cells are then sent to a specialized facility where they are genetically reprogrammed to become CAR T cells by adding tiny hooks, called chimeric antigen receptors (CAR), to their surfaces. The lab then reproduces millions of these CAR T cells to create the recommended dose of Breyanzi.
After rigorous testing and quality control, the reprogrammed CAR T cells can be infused back into the patient as their cancer-fighting therapy. Afterward, the modified cells have the potential to better recognize and attack the target cells, even types that have evaded the body’s original immune fighters. Although Breyanzi requires only a single infusion, all told, the entire process, including initial monitoring following treatment, takes two to three months.
Upward of 40 percent of LBCL patients are refractory or relapsed, meaning their cancers don’t respond to initial treatment or have come back, and in general, blood cancer patients often experience significant unmet needs after cycles of first-line therapy. In a Breyanzi study that evaluated 61 patients with second-line relapsed or refractory LBCL who were not eligible for stem cell transplant, 80 percent experienced a decrease or disappearance of their cancer, called an overall response. Of this group, 54 percent of people saw no signs of lymphoma, called a complete response or remission, and the other 26 percent had partial responses, a reduction in the amount of cancer. In some cases, remission was achieved within one month of treatment. Patients then continued regular check-ins with their health care team to monitor for and manage potential side effects.
After months of attempting prior therapies without progress, Astrid’s tumor started to shrink four weeks after her Breyanzi infusion. Her doctor explained that the CAR T cells were working and would continue to do so for the next few months. Eager to move on, Astrid powered through side effects, passed her professional certification exam and began applying for jobs — all while hoping for clear scans.
A few months after her infusion, she received the news she hoped to hear: She was in remission.
Looking back, despite the many hardships, her family of three (soon to be four!), has more than enough to celebrate.
“I thought I was going to die,” Astrid says, choking up. “Breyanzi gave me hope for the future.”
Please see Important Safety Information below and full Prescribing Information, including Boxed WARNINGS and Medication Guide.
It is important to note that there is no available data with the use of Breyanzi during or after pregnancy and it is not known if Breyanzi passes to the fetus, therefore it is not recommended for women who are pregnant. Pregnancy after Breyanzi infusion should be discussed with the treating physician.
Shifting from a Tough Prognosis to Enjoying Retirement
Dan
In 2012, Dan found an unfamiliar lump on his neck. Doctors found that the 61-year-old Massachusetts man had non-Hodgkin lymphoma. “We decided to ‘watch and wait,’ which involved scans and blood work every six months,” he recalls. However, his health began to decline – and quickly. Testing revealed his cancer had transformed to diffuse large B-cell lymphoma (LBCL) and was now choking his small intestine and a nearby artery. Despite chemotherapy, he worsened. Once incredibly active, Dan could no longer walk five feet from his bed to the bathroom. Still, he remained optimistic. His wife, Jodi, remembers, “He really did have a positive attitude. I worried more than he did.”
Preparations for a stem cell transplant began but stalled due to his rapidly declining health. “My care team explained that there probably wasn't much they could do. Probably had a few months left,” he recalls. Remarkably, shortly after, his oncologist reconnected with news of a clinical trial — and suddenly the family had a glimmer of hope.
Breyanzi first became available as a third-line treatment, meaning patients had to first try two different therapies, like stem cell transplant or chemotherapy, to be eligible. Though considered the standard of care, less than a quarter of patients are candidates for stem cell transplant, leaving many with limited options. Based on Breyanzi’s 2022 FDA approval, LBCL patients are now only required to have tried one previous therapy to access treatment, providing opportunities for deep and durable responses sooner. Studies estimate that as many as 65 percent of these patients are potentially eligible for second-line CAR T cell therapy.
“Breyanzi has opened the possibility of a complete and lasting response for the most threatened population of LBCL – those patients whose lymphoma doesn’t go away completely after first-line therapy or relapses within one year of completion of therapy,” Dr. Lunning says. “As eligible patients are identified earlier in their disease journey, the hope is that more patients will gain access to cell therapy.”
Ultimately, Dan leaped at the chance to join the Breyanzi clinical trial. He’d always been fascinated by scientific innovation and it “sounded like a really good idea if you could use your own body to fight the disease.” After receiving CAR T cell therapy, he spent several days in the hospital for observation.
“Every patient is closely monitored by the treatment facility for a week. Over the next month, they are asked to stay within two hours of the facility for continued evaluation,” Dr. Lunning says. “Patients should then expect regular checkups to track how they’re doing, treat low blood counts, mitigate the risk of infections, and monitor for potential long-term side effects from CAR T cell therapy.”
Patients should tell their doctor right away if they experience any signs and symptoms of serious side effects such as CRS and neurologic toxicities, and should be aware of common side effects of Breyanzi like fatigue, fever, muscle pain, severe nausea, vomiting, diarrhea and headache.
Please see full safety information about Breyanzi below.
After Dan received Breyanzi, he experienced recurring fevers. Still, he proudly recalls that he managed a lap around the hospital floor a few days after the infusion. “I was slow, but I could do it without sitting down!”
Approximately four weeks later, scans showed he was in remission. Not long after, Dan retired from the construction trade and fulfilled a lifelong dream with Jodi. They bought a 43-foot-long catamaran and began “chasing summer” full time.
Reflecting, Dan praises his wife’s role in his recovery. “She probably did as much to help me as the CAR T cells did,” he shared.
Please see Important Safety Information below and full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Shifting from a Tough Prognosis to Enjoying Retirement
Dan
In 2012, Dan found an unfamiliar lump on his neck. Doctors found that the 61-year-old Massachusetts man had non-Hodgkin lymphoma. “We decided to ‘watch and wait,’ which involved scans and blood work every six months,” he recalls. However, his health began to decline – and quickly. Testing revealed his cancer had transformed to diffuse large B-cell lymphoma (LBCL) and was now choking his small intestine and a nearby artery. Despite chemotherapy, he worsened. Once incredibly active, Dan could no longer walk five feet from his bed to the bathroom. Still, he remained optimistic. His wife, Jodi, remembers, “He really did have a positive attitude. I worried more than he did.”
Preparations for a stem cell transplant began but stalled due to his rapidly declining health. “My care team explained that there probably wasn't much they could do. Probably had a few months left,” he recalls. Remarkably, shortly after, his oncologist reconnected with news of a clinical trial — and suddenly the family had a glimmer of hope.
Breyanzi first became available as a third-line treatment, meaning patients had to first try two different therapies, like stem cell transplant or chemotherapy, to be eligible. Though considered the standard of care, less than a quarter of patients are candidates for stem cell transplant, leaving many with limited options. Based on Breyanzi’s 2022 FDA approval, LBCL patients are now only required to have tried one previous therapy to access treatment, providing opportunities for deep and durable responses sooner. Studies estimate that as many as 65 percent of these patients are potentially eligible for second-line CAR T cell therapy.
“Breyanzi has opened the possibility of a complete and lasting response for the most threatened population of LBCL – those patients whose lymphoma doesn’t go away completely after first-line therapy or relapses within one year of completion of therapy,” Dr. Lunning says. “As eligible patients are identified earlier in their disease journey, the hope is that more patients will gain access to cell therapy.”
Ultimately, Dan leaped at the chance to join the Breyanzi clinical trial. He’d always been fascinated by scientific innovation and it “sounded like a really good idea if you could use your own body to fight the disease.” After receiving CAR T cell therapy, he spent several days in the hospital for observation.
“Every patient is closely monitored by the treatment facility for a week. Over the next month, they are asked to stay within two hours of the facility for continued evaluation,” Dr. Lunning says. “Patients should then expect regular checkups to track how they’re doing, treat low blood counts, mitigate the risk of infections, and monitor for potential long-term side effects from CAR T cell therapy.”
Patients should tell their doctor right away if they experience any signs and symptoms of serious side effects such as CRS and neurologic toxicities, and should be aware of common side effects of Breyanzi like fatigue, fever, muscle pain, severe nausea, vomiting, diarrhea and headache.
Please see full safety information about Breyanzi below.
After Dan received Breyanzi, he experienced recurring fevers. Still, he proudly recalls that he managed a lap around the hospital floor a few days after the infusion. “I was slow, but I could do it without sitting down!”
Approximately four weeks later, scans showed he was in remission. Not long after, Dan retired from the construction trade and fulfilled a lifelong dream with Jodi. They bought a 43-foot-long catamaran and began “chasing summer” full time.
Reflecting, Dan praises his wife’s role in his recovery. “She probably did as much to help me as the CAR T cells did,” he shared.
Please see Important Safety Information below and full Prescribing Information, including Boxed WARNINGS and Medication Guide.
Breyanzi is not approved for pediatric use
A Sports Fan
‘Refuses to Lose’
David
David never expected his favorite baseball team to give him motivation to help him beat cancer. But the Seattle team’s “refuse to lose” slogan from the mid-90s helped him power through eight rounds of chemotherapy, three radiation treatments and four lumbar punctures for his large B-cell lymphoma (LBCL). He eventually received a negative scan and felt “home free.” Still, he underwent a bone marrow biopsy, an optional test to validate that his treatment worked.
In hindsight, David’s glad he didn’t skip that step – the cancer was still there.
A doctor recommended that David put his affairs in order, as he likely had less than six months to live. He recalls: “I was 58 and my two sons were entering their freshman year of college and senior year of high school. Plenty of life’s accomplishments lay ahead for them, if not for me. I said, ‘No way am I giving up now.’ So, I started to learn more about CAR T cell therapy.”
In 2017, he joined a Breyanzi clinical trial. Like many LBCL patients, David experienced adverse events after receiving treatment. He endured a fever from CRS, as his immune system reacted to the immunotherapy, but with the critical help of his wife, sons and supportive care team, he navigated these side effects with confidence.
During these hardest points, David’s community lifted him up. “People made us meals, gave me rides to appointments. And I don’t just mean my three best friends, but the next circles out,” he recalls emotionally. “I firmly believe that had something to do with my recovery, even if it only strengthened my will and reminded me that the decision to keep fighting was a good one.”
Only a month later, the tumors had subsided, and within six months, David achieved complete remission. Now he takes every opportunity to enjoy life, spending time with his family and taking exercise classes. With the time they once worried they wouldn’t have, David and his wife have also started traveling to their dream destinations, including a recent cruise to Greece and Turkey.
His message for other patients facing lymphoma and considering CAR T cell therapy with Breyanzi?
“Don’t give up. Take every opportunity for treatment, medication, or anything that could improve your outcome. I hate to sound flippant, but what do you have to lose?”
Breyanzi is not approved for pediatric use
A Sports Fan
‘Refuses to Lose’
David
David never expected his favorite baseball team to give him motivation to help him beat cancer. But the Seattle team’s “refuse to lose” slogan from the mid-90s helped him power through eight rounds of chemotherapy, three radiation treatments and four lumbar punctures for his large B-cell lymphoma (LBCL). He eventually received a negative scan and felt “home free.” Still, he underwent a bone marrow biopsy, an optional test to validate that his treatment worked.
In hindsight, David’s glad he didn’t skip that step – the cancer was still there.
A doctor recommended that David put his affairs in order, as he likely had less than six months to live. He recalls: “I was 58 and my two sons were entering their freshman year of college and senior year of high school. Plenty of life’s accomplishments lay ahead for them, if not for me. I said, ‘No way am I giving up now.’ So, I started to learn more about CAR T cell therapy.”
In 2017, he joined a Breyanzi clinical trial. Like many LBCL patients, David experienced adverse events after receiving treatment. He endured a fever from CRS, as his immune system reacted to the immunotherapy, but with the critical help of his wife, sons and supportive care team, he navigated these side effects with confidence.
During these hardest points, David’s community lifted him up. “People made us meals, gave me rides to appointments. And I don’t just mean my three best friends, but the next circles out,” he recalls emotionally. “I firmly believe that had something to do with my recovery, even if it only strengthened my will and reminded me that the decision to keep fighting was a good one.”
Only a month later, the tumors had subsided, and within six months, David achieved complete remission. Now he takes every opportunity to enjoy life, spending time with his family and taking exercise classes. With the time they once worried they wouldn’t have, David and his wife have also started traveling to their dream destinations, including a recent cruise to Greece and Turkey.
His message for other patients facing lymphoma and considering CAR T cell therapy with Breyanzi?
“Don’t give up. Take every opportunity for treatment, medication, or anything that could improve your outcome. I hate to sound flippant, but what do you have to lose?”
INDICATIONS AND IMPORTANT SAFETY INFORMATION
What is BREYANZI?
BREYANZI is a prescription medicine used to treat adults with large B-cell lymphoma (LBCL), a type of non-Hodgkin lymphoma, when:
- your first treatment has not worked or your cancer returned within a year of completion 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.
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 (intravenous infusion). 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 after infusion, you will be monitored daily by the facility where you received your treatment.
- You should plan to stay within 2 hours of the location where you received your treatment 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. 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 do 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
- low blood pressure
- muscle pain
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.
BREYANZI may increase your risk of getting cancers including certain types of blood cancers. Your healthcare provider should monitor you for this.
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.
© 2024 Bristol Myers Squibb. All rights reserved. 2009-US-2400636. 10/24.