| Common Brands | Breyanzi |
|---|---|
|
Drug Class |
CAR-T therapy |
|
Controlled Substance Classification |
Not a controlled medication |
|
Generic Status |
No Lower-cost generic available |
|
Availability |
Prescription only |
Breyanzi, generic name: lisocabtagene maraleucel, is a chimeric antigen receptor T-cell therapy drug for the treatment of certain cancers, particularly large B-cell lymphoma, a non-Hodgkin’s lymphoma. It was designed to treat patients with lymphoma who have failed or have relapsed after previous treatments. Specifically, Breyanzi is administered in adult patients with relapsed or refractory large B-cell lymphoma, including DLBCL, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma after failure of at least two lines of previous therapy.
Breyanzi works through the body’s inherent immune system to target cancer cells and kill them. It is an advanced form of treatment that falls in the category of advancing immunotherapy, according to which the body’s immune system is used to combat cancer in new ways.
Breyanzi is not given as a pill or injection. It is cell-based therapy, and its administration is a complex series of steps:
Apheresis The first step is collection of the patient’s T-cells. This process occurs through a procedure known as apheresis, whereby blood from the patient is drawn, separated from its T-cells, and returned to the patient. Usually, this process lasts several hours.
The collected T-cells are then sent to a specialized facility where they are genetically engineered to express the CAR (chimeric antigen receptor) that targets CD19. Then, the T-cells are expanded, meaning they multiply in the lab to create many CAR-T cells.
Infusion: After preparation of T-cells, the patient returns to the healthcare facility, where these modified T-cells are infused back into the bloodstream using an intravenous (IV) line. The infusion process usually lasts for about 30 minutes to an hour.
Monitoring: The patient was very closely monitored after the infusion as CAR-T cell therapy could lead to severe side effects such as CRS, neurologic events. Monitoring often takes place in hospital settings for a few days to ensure safety.
Breyanzi works via a process of CAR-T cell therapy. The engineered T-cells have receptors designed to identify and attach to CD19 from the surface of B-cells. CD19 is a transmembrane protein present both on normal and cancerous B-cells. Targeting it, Breyanzi permits one’s T-cells to recognize and destroy cancerous B-cells that are in existence in lymphoma.
After the infusion, modified T-cells circulate through the blood, scan for CD19-positive B cells, and attach to them. That attachment activates the T-cells to kill the cancerous cells through cytolysis, where the T-cells release toxins that lead to the death of the cell being targeted.
Breyanzi is very potent in destroying and eradicating the malignant B-cells especially when other treatments have failed. This includes relapsed or refractory lymphoma.
While Breyanzi is a promising treatment, it is not without risks. The most common side effects include:
CRS: CRS is a systemic inflammatory response when the CAR-T cells become activated and release high quantities of cytokines, which are proteins within the immune system. CRS might lead to fever, fatigue, low blood pressure, respiratory distress, and organ failure. Severe CRS may require in-patient care and certain medications, such as tocilizumab, an immunomodulatory drug.
Neurologic Toxicity: Neurologic toxic effects can include confusion, difficulty in speaking, seizures, and loss of consciousness. They can be reversible but are serious enough and require close monitoring.
Infections: Because CAR-T therapy temporarily weakens the immune system, there is a higher risk of infections such as bacterial, viral, and fungal infections.
Low Counts of Blood Cells: CAR-T cells infusion leads to low counts of red blood cells, white blood cells, and platelets. These low counts can cause anemia, infection, and bleeding.
Cytokine Release Syndrome (CRS) and Neurologic Events: CRS and neurologic toxicities are serious and potentially life-threatening side effects of Breyanzi. These side effects typically occur within the first few days after the infusion, and patients should be closely monitored for at least 7 days after receiving Breyanzi.
Infections: CAR-T therapy can compromise the immune system, leading to a higher risk of infections. Patients may need prophylactic antibiotics and antiviral medications during treatment.
Pregnancy and Breastfeeding: Breyanzi should not be used during pregnancy or breastfeeding. It is not known whether the drug can harm a developing fetus or pass into breast milk, so women should avoid pregnancy for at least 6 months after treatment.
Always consult with your healthcare provider for guidance when combining Breyanzi with other treatments.
Breyanzi is administered as a single intravenous infusion after the T-cells have been genetically modified and expanded in the laboratory. The dose is personalized based on the patient’s condition and overall health. The infusion is typically delivered over 30 minutes to an hour, and the patient will be monitored for any immediate reactions.
Breyanzi is a prescription-only product, and the administration may be done only by properly qualified healthcare professionals who have experience in giving CAR-T therapies. The service will be delivered in specialized facilities to manage the potential life-threatening complications like CRS and neurologic toxicity.
Breyanzi (lisocabtagene maraleucel) is a type of CAR T-cell therapy designed to treat certain types of large B-cell lymphoma, a form of non-Hodgkin lymphoma.
Breyanzi works by modifying a patient’s own T-cells to recognize and attack cancer cells. This involves extracting T-cells from the patient, modifying them in the lab, and then infusing them back into the patient’s bloodstream.
Breyanzi is specifically indicated for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systematic therapy, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma.
Breyanzi is administered as an intravenous (IV) infusion, typically after the patient undergoes apheresis (a procedure to collect T-cells) and subsequent cell processing.
The treatment process includes T-cell collection, cell modification in a lab (which takes about two weeks), and then the administration of the modified T-cells as an infusion.
Common side effects can include fever, fatigue, headache, low blood cell counts, infusion-related reactions, and neurologic symptoms such as confusion or difficulty speaking.
Yes, serious side effects can include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). These can be severe and require immediate medical attention.
Breyanzi is typically prescribed to adults with specific types of relapsed or refractory large B-cell lymphoma who have not responded to at least two prior therapies. Eligibility should be assessed by a healthcare provider.
The entire process, from T-cell collection to infusion, can take several weeks. Once the T-cells are ready, the infusion itself usually takes about 30 minutes to an hour.
Yes, because Breyanzi can lower your blood cell counts, it may increase your risk of infections. Patients are monitored closely for signs of infection before and after treatment.
Breyanzi is generally used as a standalone therapy for relapsed or refractory lymphoma, but your doctor may provide specific advice regarding previous or future treatments.
Clinical studies have shown that Breyanzi can lead to significant improvements in response rates in patients with certain types of relapsed or refractory large B-cell lymphoma, with many achieving complete remission.
Patients should report any side effects, especially severe or unusual symptoms, to their healthcare provider immediately. Regular follow-ups are essential for monitoring side effects.
Breyanzi is not recommended for use during pregnancy or breastfeeding due to potential risks to the baby. Women should use effective contraception during and after treatment as advised by their healthcare provider.
Patients are closely monitored for side effects and effectiveness through lab tests, physical exams, and regular follow-up appointments, especially in the weeks following the infusion.
There are no specific dietary restrictions associated with Breyanzi, but patients should discuss any dietary changes or concerns with their healthcare provider.
The duration of response varies among patients. Some may achieve long-term remission, while others may require further treatment depending on their individual response.
Breyanzi treatment is typically administered in specialized treatment centers equipped to handle CAR T-cell therapy, due to the need for careful monitoring and supportive care.
The cost of Breyanzi can be significant and varies based on healthcare plans and treatment facility. Patients should talk to their healthcare provider and insurance company for specific pricing information and availability of financial assistance.
For more information, consult your healthcare provider, refer to the prescribing information provided with the drug, or visit the official website of the manufacturer and reputable health organizations.
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