Breyanzi (lisocabtagene maraleucel) is a type of treatment called a chimeric antigen receptor T-cell therapy (CAR T-cell) that uses your body's own immune system to treat your cancer. Breyanzi was approved in 2024 to treat a type of non-Hodgkin lymphoma called large B-cell lymphoma (LBCL). Below you’ll find common questions and answers about Breyanzi to help decide whether it’s right for you.
What Kinds of Lymphoma Does Breyanzi Treat?
Breyanzi treats LBCL that:
- Has come back (relapsed) within a year of treatment or does not go away (refractory) after your first treatment
- Has relapsed or is refractory and you cannot receive a hematopoietic stem cell transplantation (HSCT)
- Has relapsed or is refractory to at least two other types of treatment
How Will I Get Breyanzi?
The first step involves collecting your white blood cells (T cells) through a process called apheresis. This procedure separates your T cells from the rest of your blood, which is then returned to your body. These T cells are then sent to a manufacturing site where a receptor called CAR is added to them, making them Breyanzi CAR T cells. This process usually takes about three to four weeks, but the time frame can vary.
About two to seven days before you receive Breyanzi, you will get three days of chemotherapy to prepare your body. Then, Breyanzi is given as two separate cell infusions that are put into your vein (intravenous). You will get Breyanzi at a health care facility that is authorized to give this type of treatment. You will be monitored daily for one week by your health care provider at the facility where you got Breyanzi. You will need to stay close to the facility for about four weeks after that. Your health care provider will monitor you for any side effects during this time. If you have side effects, you may need to be hospitalized.
How Does Breyanzi Work for Lymphoma?
Breyanzi will start to work after your Breyanzi CAR T cells are infused back into your body, where they begin to multiply. The CARs that are attached to your body’s T cells help the cells to more effectively identify and attack cancer cells. The CAR T cells recognize a marker found on both cancer cells and some normal cells, enabling Breyanzi and your immune system to locate and fight the cancer.
How Was Breyanzi Studied?
Breyanzi was studied in people with relapsed or refractory LBCL that had come back within 12 months of their initial treatment and were candidates for autologous HSCT (transplant from your own stem cells). People got either Breyanzi or standard of care (SOC) chemotherapy followed by HSCT for those who had a response. The primary endpoint of this study was event-free survival (EFS), which was how long people were free of any event such as cancer progression, recurrence, or death. The study also looked at progression-free survival (PFS), which measured the length of time people went without progression of their cancer or death, and complete response rate (CRR). Complete response means that after treatment, there are no signs of cancer. There were 184 people in this study and they were split evenly between the two groups. The median age was 59 years old (range: 20 to 75) and 57% of people were male. Fifty-nine percent were White, 10% were Asian, and 4% were Black. Median EFS was significantly longer in the Breyanzi group at 10.1 months versus 2.3 months in the SOC group. This means that people that got Breyanzi went an average of about eight months longer without progression, relapse, or death than those who did not get Breyanzi. EFS rates were also longer in the Breyanzi group (63%) versus the SOC group (33%) at six months. Sixty-six percent of people that got Breyanzi had a complete response and 39% of people who got SOC had a complete response. This means that 66% of people that got Breyanzi had no signs of cancer after their treatment. After Breyanzi, the median time of progression-free survival, meaning people saw no progression of their cancer, was 14.8 months versus 5.7 months for those that did not get Breyanzi.
Breyanzi was also studied in people who were not eligible for an HSCT and had relapsed or refractory LBCL. There was one group in this trial where people received chemotherapy followed by Breyanzi. This study looked at overall response rate, which measured how many people had either a complete response (CR) or a partial response (PR) to Breyanzi. A CR is when all of the tumor has disappeared and a PR is when the tumor has decreased in size by at least 50%. It also looked at duration of response (dOR), which measured how long the response lasted. There were 74 people in the trial and 61 of them got Breyanzi. Of the 61 patients who received Breyanzi, the median age was 74 (range: 53 to 84) and 61% were male. Most of the people were at least 70 years old (79%). Eighty-nine percent of people were White, 3% were Asian, and 2% were Black. About 12 months after getting Breyanzi, 80% of people had a response, and 54% had a CR. This means that 54% of people had no signs of cancer. The median time that response lasted was 11.2 months, and in patients with a CR, the median duration of response was 21.7 months.
Another study looked at Breyanzi in people whose LBCL had relapsed or was refractory after two previous types of treatment. People were allowed to be in this trial if they had a previous HSCT. There was one group in this trial where people received chemotherapy followed by Breyanzi. The study looked at objective response rate (ORR), which measured how effective Breyanzi was by looking at the percentage of people who had either a PR or CR. It also looked at the dOR. The median age in this trial was 63 (range: 18 to 86) and 69% were male. Eighty-four percent of the people were White, 6% were Black, and 4.7% were Asian. Seventy-three percent of the people had a response to Breyanzi and 54% had a complete response. In people that had any type of response, the response lasted about 16.7 months.
What Are Some Unique Considerations to Be Aware Of?
Breyanzi can cause a serious side effect called cytokine release syndrome (CRS). CRS happens when your body has an exaggerated reaction to either an infection or immunotherapy. Your body responds by releasing cytokines, and sometimes these cytokines cause fevers and problems in some of your organs. Your health care provider will watch you for CRS symptoms, such as severe headache, fever, and increased heart rate. If you develop any symptoms of CRS, your health care provider may give you medicine to treat it. Your health care provider should give you a Breyanzi Wallet Card, which lists all the signs and symptoms of CRS. You should carry this with you all the time.
Breyanzi may cause serious neurologic problems. Your health care provider will monitor you for signs of neurologic problems including confusion, headache, difficulty speaking, seizures, or changes in your mental status. If you develop any of these symptoms, you should contact your health care provider right away. You may need to be treated with a medicine called a corticosteroid or a medicine used to treat seizures.
Severe infections can occur while taking Breyanzi. You can help reduce your risk of developing an infection by washing your hands often and staying away from people with infections, colds, or the flu. If you are at high risk for getting an infection, your health care provider may prescribe a medicine to help prevent infections. You should contact your health care provider right away if you develop a fever or any other signs of an infection such as a sore throat or cough, as you may need antibiotics or other medicine to treat your infection.
Your health care provider will review your vaccination record and recommend any vaccines you may need prior to starting Breyanzi. You should not get any live vaccines six weeks before using Breyanzi, during treatment, and after your immune system recovers from the medicine. Live vaccines include measles, mumps, rubella (MMR), and chickenpox.
It is unknown if Breyanzi can cause harm to a fetus or will pass into your breast milk. You should tell your health care provider if you are pregnant or plan on becoming pregnant before starting Breyanzi.
Breyanzi may cause other types of cancers such as certain types of blood cancers. Your health care provider will monitor you for this.
What Are the Possible Side Effects of Breyanzi, and How Can I Prevent or Manage Them?
The most common side effects of Breyanzi are feeling tired, low blood cell counts, muscle pain (arthralgias), and nausea.
Feeling tired is a common side effect of Breyanzi, but there are some things you can do to help increase your energy. Exercising each day, even if it is just for a short time, can help boost your energy. Eating a healthy diet of fruits, vegetables, lean protein, and whole grains while avoiding sugary foods may also help you fight fatigue. Your doctor may be able to give you medicines to treat other side effects such as depression, pain, or low blood counts, which may help with your fatigue.
Breyanzi can cause low blood cell counts, including low platelets (thrombocytopenia), low white blood cells (neutropenia), and low red blood cells (anemia). Thrombocytopenia can cause you to bruise or bleed easier than normal. Things you can do to prevent this include using an electric shaver instead of a razor, using a soft bristled toothbrush to brush your teeth, and avoiding contact sports. Neutropenia can cause severe infections. You can help reduce your risk of developing an infection by washing your hands often and staying away from people with infections, colds, or the flu. If you are at high risk for getting an infection, your health care provider may prescribe a medicine to help prevent infections. You should contact your health care provider right away if you develop a fever or any other signs of an infection such as a sore throat or cough. They may prescribe medicine to treat your infection. Anemia can make you feel more tired than usual and have shortness of breath. Eating foods rich in iron such as spinach and red meat may help boost your energy. You should contact your health care provider if you have these symptoms so your blood counts can be monitored.
You may also experience muscle, bone, or joint pain while taking Breyanzi. Your health care provider may recommend that you use over-the-counter pain relievers such as acetaminophen or ibuprofen. You should contact your health care provider if you have pain that does not go away with over-the-counter medicines.
Breyanzi may cause gastrointestinal (GI) side effects such as nausea. Your health care provider may give you certain medicines to prevent these side effects from happening, as well as medicines to treat them if they occur. Eating bland food and smaller meals throughout the day can help with symptoms of nausea.
How Will I Know if Breyanzi Is Working?
You may see a response to Breyanzi in as little as one month, but it may take longer. Your health care provider will assess your response by monitoring your blood tests and imaging studies such as PET scans or CT scans.
How Can I Get Breyanzi?
Your cancer doctor (oncologist) will arrange for you to receive Breyanzi in a health care setting, such as a hospital or infusion center.
If you need support paying for Breyanzi, the drugmaker may be able to help you. Check out their Bristol Myers Squibb Financial Support website at www.breyanzi.com/support/support-program to learn more about their patient assistance program or to ask your questions about insurance coverage and out-of-pocket costs. You can also contact the drugmaker at 888-805-4555.
