What to Know About Breyanzi for Leukemia and Lymphoma

CAR T-cell therapy. If you haven’t heard of it, it may sound like a spa for car lovers. But if you’ve heard of it, you may recognize it as an intriguing new treatment option for hard-to-treat cancers. And that’s exactly what it is.

More specifically, chimeric antigen receptors (CAR) T-cell therapy is a form of immunotherapy. It’s a process that involves taking T-cells from your immune system and genetically modifying them in a lab so they can fight cancer more effectively.

Today, there are a few different CAR T-cell medications. One of the newer ones is called Breyanzi (lisocabtagene maraleucel). It was initially approved in early 2021 as another option to treat specific types of blood cancer. But why is it unique? And is it actually effective at treating cancer that hasn’t responded well to other treatments?

Here, we’ll talk about Breyanzi — what it is, how it works, and how much it costs.

What is Breyanzi?

Breyanzi is a CAR T-cell therapy that’s approved to treat certain types of leukemia and lymphoma in adults, which are common forms of blood cancer. Since it works by genetically modifying some of your cells, Breyanzi is also considered to be a type of gene therapy.  

Breyanzi is used in a few specific situations. It can treat a few types of B-cell lymphoma in adults:

• Diffuse large B-cell lymphoma

• High-grade B-cell lymphoma

• Primary mediastinal large B-cell lymphoma

• Follicular lymphoma

Breyanzi isn’t a first-choice option for treating these types of lymphoma, though. You can receive it, however, if your body didn’t respond well to initial treatment with chemotherapy and immunotherapy. You can also receive it if two or more previous treatments didn’t work.

Breyanzi’s list of uses goes on. You can receive it if you have chronic lymphocytic leukemia or small lymphocytic lymphoma. It’s actually the first CAR T-cell therapy to be approved for these uses. But you should only receive it if you’ve already tried two other treatments first, such as Imbruvica (ibrutinib) and Venclexta (venetoclax).

Breyanzi is also unique for a regulatory reason. It was the first medication to be approved with the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation. This designation is given to medications that aim to treat life-threatening diseases and have the potential to fill unmet medical needs.

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How does Breyanzi work for lymphoma?

B cells are immune system cells that help your body fight infections. Also called B lymphocytes, their main job is to make defense-oriented antibodies. But some cancers, like certain types of lymphoma, infect your B cells.

Breyanzi works by targeting cancerous B cells. It does this by helping your immune system find and fight cancerous B cells more effectively. The CAR T-cell process genetically programs your T cells to make a special connector that can attach to a protein on cancerous B cells. This protein is called CD19.

T cells are also immune system cells, and they’re directly involved in killing foreign invaders, like germs and cancer. But because they fight against so many possible threats, it can be hard for them to find and recognize a specific cell.

By genetically programming them to identify a specific target like CD19, your T cells have a better chance of finding and fighting your cancer more effectively.

How is Breyanzi given when treating lymphoma?

Your Breyanzi dose is personalized for you. To get the process started, your blood will be collected and sent to a lab. It will be at the lab for a few weeks so it can be transformed into Breyanzi. It’ll then be sent back to your cancer care team so they can give you your treatment.

But a few days before you get Breyanzi, you’ll receive chemotherapy for 3 days. This is done to kill your existing T-cells before you receive Breyanzi. This helps prepare your body for the medication — it’s also known as a preparative regimen.

When it’s time to receive Breyanzi, it’s given as two back-to-back 15 minute infusions into your vein. These are only given a single time.

However, Breyanzi can cause a number of side effects. To help get ahead of potential infusion-related reactions, you’ll likely get doses of diphenhydramine (Benadryl) and acetaminophen (Tylenol) about 1 hour before your Breyanzi infusion.

How effective is Breyanzi when treating lymphoma?

Most of what we know about Breyanzi’s effectiveness comes from clinical trials.

In a key study that helped lead to its initial FDA approval, Breyanzi’s complete response rate was 54% for people with large B-cell lymphoma. This means that about 54% of people in the study saw a disappearance of all signs of their cancer. And its overall response rate was about 73%. This means that 73% of people saw at least some (if not all) of their cancer go away.

Plus, additional data suggests that Breyanzi can help extend event-free survival when compared to some other widely-used treatments for large B-cell lymphoma. Event-free survival means your cancer has gone away and you're not having any complications.

Separately, Breyanzi’s approval for chronic lymphocytic leukemia and small lymphocytic lymphoma is more recent. In March 2024, its manufacturer released data that shows its complete response rate for these uses was about 20%. The overall response rate was closer to 45%.

Remember: These are general statistics from a large number of people. They may or may not be representative of your situation. If you’re curious how effective Breyanzi may be for you, talk to your cancer specialist. They can give you a more accurate picture of what to expect.

What are the potential side effects?

Like all medications, Breyanzi has a number of side effects. Some are common, and others are more rare. But they’re all important to be aware of.

Common side effects

In Breyanzi’s clinical trials, the following side effects happened to at least 20% of people who received the medication:

• Cytokine release syndrome (CRS), a potentially serious immune response

• Tiredness (fatigue)

• Muscle pain 

• Nausea

• Diarrhea

• Smaller appetite than normal

• Headache

• Dizziness

• Fever

• Cough

• Low blood pressure

• Fast heart rate

• Swelling in the arms or legs

• Low blood cell counts and infection

• Encephalopathy

Although these side effects were relatively common in clinical trials, that doesn’t guarantee you’ll experience them. Side effects can also vary by cancer type. If you do have side effects, you may experience some of these listed side effects, other ones that aren’t described, or some combination of the two.

Serious side effects

Some of Breyanzi’s side effects are serious and potentially fatal. When these types of side effects are suspected, you should seek medical attention right away.

In fact, Breyanzi carries three boxed warnings — the FDA’s most serious type of warning it can give a medication. This includes:

1. CRS: Symptoms of this immune-related reaction can include fever, low blood pressure, a fast heartbeat, chills, and others.

2. Neurological problems, with or without CRS: Symptoms may include confusion, tremors, seizures, lack of coordination, and more.

3. Secondary cancers: Medications such as Breyanzi have occasionally been linked to causing new cancers related to T cells in your blood.

Because of these risks, the FDA has implemented a Risk Evaluation and Mitigation Strategies (REMS) program, called the Breyanzi REMS. The Breyanzi REMS program helps make sure that Breyanzi’s benefits outweigh its risks for you.

Other potentially serious side effects are also possible, but they don’t have boxed warnings. This includes risks like the potential for allergic reactions, a higher risk for serious infections, and altered blood cell counts.

How much does Breyanzi cost?

Even though CAR T-cell therapy medications such as Breyanzi are only given a single time, they can be a financial strain. Breyanzi’s list price is reported to be over $487,000 for one treatment. But there are ways you can save.

If you have insurance, this can help bring costs down. But specific coverage will vary depending on your plan type. For more information about your expected out-of-pocket costs through your insurance, it’s recommended to talk to your plan provider.

Financial assistance from Breyanzi’s manufacturer is also available. This is through a program called Cell Therapy 360. If you have commercial insurance, this program may cover your out-of-pocket costs for the medication. For more information, call 1-888-805-4555 or visit Cell Therapy 360 online.

What are some alternatives to Breyanzi?

There are a few other CAR T-cell therapies that can also treat lymphoma. This includes Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel), and Tecartus (brexucabtagene autoleucel).

Your cancer specialist may choose one of these medications for you depending on your type of lymphoma, treatments you’ve received previously, and other medical conditions you may have. But if your specialist ends up choosing Breyanzi as your next step in treatment, you’ll receive the infusion at an authorized treatment center.

Why trust our experts?

Written by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

Reviewed by:

Sonja Jacobsen, PharmD, BCPS, BCOP

Sonja Jacobsen, PharmD, BCPS, BCOP,  is a clinical oncology pharmacy specialist currently practicing in Seattle. She has been practicing as a pharmacist since 2015 and is licensed to practice in Washington state and North Carolina.

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