FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma

The U.S. Food and Drug Administration has approved Breyanzi^® (lisocabtagene maraleucel) as a new treatment for diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common type of non-Hodgkin lymphoma in adults. About one-third of all non-Hodgkin lymphoma diagnoses are DLBCL.¹

Breyanzi is approved for people who have relapsed or refractory DLBCL. Refractory means the cancer has stopped responding to treatment. People must have tried at least 2 other treatments before trying Breyanzi. Breyanzi is not approved for people with primary central nervous system lymphoma.¹

How does Breyanzi work?

Each dose of Breyanzi is custom-made for the person receiving it.

A Breyanzi treatment is created using the patient’s own T-cells. A T-cell is a special white blood cell. The immune system uses T-cells to attack viruses. For a Breyanzi dose, the person’s T-cells are genetically modified. This modification teaches the T-cells to identify and kill lymphoma cells.^1,3

To make a dose of Breyanzi, first your T-cells are collected with a process called leukapheresis. During leukapheresis, blood is drawn and passed through a machine that removes white blood cells. The remaining blood cells are infused back into your body.²

Your T-cells are then sent to a facility to be genetically modified. This can take 3 to 4 weeks, plus shipping time. Before getting your Breyanzi dose, you will get chemotherapy for 3 days to prepare your body. Once your dose is ready and you have completed chemotherapy, your modified T-cells are infused back into your body.^1,2

Evidence for Breyanzi

Breyanzi’s approval was based off a clinical trial of about 250 adults with DLBCL. Researchers found that after their Breyanzi treatment, a little more than half of the people in the trial had complete remission. This means that tests, exams, and scans show no signs of cancer. Breyanzi is the third gene therapy the FDA has approved for certain types of non-Hodgkin lymphoma.¹

What are the possible side effects of Breyanzi?

Treatment with Breyanzi may cause severe side effects. The 2 most common serious side effects are cytokine release syndrome (CRS) and neurologic toxicities.²

During CRS, the immune system overreacts and overproduces cytokines, which are small proteins. CRS can be life-threatening. Some signs of CRS are flu-like symptoms, including fever, nausea, headache, rapid heartbeat, and trouble breathing.⁴

Neurologic toxicities are another possible serious side effect of Breyanzi. This happens when the chemicals from the dose impact the nervous system. Neurologic toxicities can be fatal. Some signs of neurologic toxicities are confusion, headache, and dizziness.⁵

If you experience any trouble breathing or other side effects that you think may be life-threatening, immediately contact 911 to report a medical emergency.

These are not all the possible side effects of Breyanzi. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Breyanzi.

Things to know about Breyanzi

Because of the risk of CRS and neurologic toxicities, the FDA has given special guidelines for how Breyanzi is given. The healthcare facilities that dispense Breyanzi will need a special certification. Also, the healthcare workers who prescribe or give Breyanzi will have special training in recognizing signs of CRS and neurologic toxicities.¹

People receiving Breyanzi will also have special instructions. For the first week, they should be monitored by the facility that gave them their dose. They also should stay close to the facility for 4 weeks after getting the dose. The facility will tell them what warning signs to look out for in case of serious side effects.²

To confirm the safety of the drug, the FDA is also requiring the maker of Breyanzi to continue a long-term study of the people who take it.¹

For more information, read the full prescribing information of Breyanzi.