Breyanzi(lisocabtagene maraleucel) is a type of personalized cancer treatment called chimeric antigen receptor (CAR) T-cell therapy, which uses your modified T cells (white blood cells that help protect you from illness) to fight cancer. The FDA has approved Breyanzi for adults with a certain type of blood cancer known as marginal zone lymphoma (MZL) that has come back (relapsed) or hasn’t responded well to two or more previous therapies (refractory).
MZL is a rare slow-growing type of non-Hodgkin’s lymphoma (NHL) – a form of blood cancer. It arises from B cells or B lymphocytes (another type of white blood cells) found in the marginal zone of lymphoid tissues. MZL makes up about 7% of all NHL cases in the U.S., often affecting adults around 67 years old. It occurs when white blood cells gather and form lumps in the lymph nodes or other organs. Although initial treatment for the disease can help achieve remission, relapses are common and may happen often over several years. In a small number of cases, MZL can transform into diffuse large B-cell lymphoma, a more aggressive form of the disease.
This approval is important because Breyanzi is the first and only CAR T-cell therapy available in the U.S. for treating MZL. It offers people with this hard-to-treat cancer a new option when other treatments have stopped working.
First approved in 2021, Breyanzi has also been approved for the treatment of several other blood cancers that have come back or didn’t respond to earlier treatments, including large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma.
The FDA approval for Breyanzi was based on a clinical study that showed that it was safe and effective in significantly reducing MZL in adults whose cancer had come back or had not responded after at least two previous treatments or after a stem cell transplant.
What Do I Need to Know?
Breyanzi is given as a one-time IV infusion. Before starting the treatment, your T cells will be collected through a process called leukapheresis and will be sent to the manufacturing site for creating personalized CAR T cells. However, before collecting your T cells, your health care provider may also test you for hepatitis B and C and HIV according to clinical guidelines. You’ll also get a short course of preparatory chemotherapy for three days before the infusion to help prepare your body. The whole process can take a few weeks.
You should avoid driving or using heavy machinery for at least two weeks after receiving Breyanzi since side effects, like confusion or dizziness, may show up later. Avoid donating blood, organs, tissues, or cells for transplantation.
Before receiving Breyanzi, tell your health care provider about any medical problems that you have or have had, including neurologic issues (like seizures, stroke, or memory loss); lung or breathing problems; heart, liver, or kidney issues; allergies; or any recent or ongoing infections. Also let them know about all your vaccinations and the medications, vitamins, and herbal supplements you take. It is recommended to avoid live virus vaccines for six weeks before preparatory chemotherapy, during treatment, and until your immune system recovers afterward.
Breyanzi is not recommended if you are pregnant, and its effects on breastfeeding are not known. It may also affect certain lab test results, such as those for HIV, and could produce false-positive results.
Your health care provider will also guide you on how to watch for signs and symptoms of CRS and neurologic complications. Contact your health care provider or get emergency help right away if you have a fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, a fast or irregular heartbeat, dizziness, unusual bleeding or bruising, or severe exhaustion or weakness. These could be signs of serious side effects.
