by Blood Cancer United
Liso-cel (Breyanzi®) is now approved to treat five types of blood cancer
WASHINGTON, Dec. 5, 2025 – The U.S. Food and Drug Administration has approved the CAR T-cell therapy lisocabtagene maraleucel (liso-cel, Breyanzi®) to treat adults with marginal zone lymphoma that has either not responded or has returned after two previous types of treatment.
CAR T-cell therapy gives a patient’s immune system the tools it needs to kill cancer cells. In the case of liso-cel, the patient’s T-cells are modified to target and kill cancer cells that have the CD19 protein on their surface.
Blood Cancer United®, formerly The Leukemia & Lymphoma Society, supported some of the earliest research leading to the first FDA approvals for this type of groundbreaking personalized immunotherapy, which is usually given as a one-time infusion.
“Every CAR T approval is a step forward for patients, and a reminder that early and consistent research funding is so important,” says Lore Gruenbaum, Ph.D., Chief Scientific Officer, Blood Cancer United. “In the 1990s, scientists were struggling to get funding for the work that would evolve into CAR T. Blood Cancer United saw the promise and took a risk few others would take. Our donors should take great pride in their contributions to make this happen.”
In the clinical trial that the FDA reviewed in approving liso-cel, 95.5% of patients responded to treatment with liso-cel and 62.1% had a complete response, with their cancer undetectable on imaging scans. The responses were durable after a median follow up of 21.6 months.
Liso-cel is now approved to treat five types of blood cancer: large B-cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma.
Several other CD19-directed CAR T-cell therapies are available to treat these blood cancer types as well as B-cell acute lymphoblastic leukemia. In addition, several CAR T-cell therapies targeting BCMA are available to treat multiple myeloma.
Working to improve CAR T-cell therapy and extend its benefit to more patients
Typically, CAR T-cell therapy is given as a one-time infusion at a specialized center. In some cases, treatment leads to long-term remissions and even cures, including in patients facing a very poor prognosis with limited or sometimes no other treatment options.
But CAR T-cell therapy doesn’t work for every patient. It also takes weeks to prepare—time some blood cancer patients don’t have. This type of therapy can be hard to access for people who do not live near specialized centers, which tend to be located in larger metropolitan areas.
Blood Cancer United has invested more than $100 million in immunotherapy, including $50 million in CAR-T and counting. Blood Cancer United is investing in scientific research to address the limitations of personalized CAR therapy.
Our expert staff scientists work closely with research and clinical leaders to assess which studies will help provide answers to key questions: how to adjust current treatments, how to make them effective in more people, how to make effects of therapy last longer, how to speed up the process of making personalized CAR T-cells, and how to make these therapies safer so that they can be administered in settings beyond the specialized care centers required today.
Blood Cancer United is also investing in new CAR immunotherapy approaches that produce more potent cells, attack novel cancer targets (alone or in combination), or use other types of immune cells, for example “natural killer” (NK) cells. This next generation of therapies may provide longer lasting effectiveness and work for more types of blood cancer.
If you or a loved one need personalized disease, treatment or support information, you can contact one of our Information Specialists: https://www.lls.org/support-resources/information-specialists
To interview an expert, please contact [email protected].
About Blood Cancer United®
Blood Cancer United® (formerly The Leukemia & Lymphoma Society) is the largest global nonprofit focused on blood cancer patient support, research, and advocacy. The organization’s mission is to cure blood cancer and improve the quality of life of all patients and their families. To achieve it, Blood Cancer United brings together a community of people—patients and their families, volunteers, healthcare providers, scientists, staff, partners, fundraisers, and philanthropists—who believe all blood cancer patients deserve longer, fuller lives.
Since the organization’s founding in 1949, it has consistently evolved to better serve people affected by all 100-plus types of blood cancers—including leukemia, lymphoma, myeloma, myelodysplastic syndromes, and myeloproliferative neoplasms.
Blood Cancer United offers free, trustworthy resources, personalized support, and community for anyone affected by blood cancer. The organization has invested more than $2 billion in research, which continues to increase survival rates. Blood Cancer United advocates nationally and locally for more accessible and affordable healthcare for all patients.
For support and to learn more, visit www.BloodCancerUnited.org. Patients can contact blood cancer information specialists at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET. Connect with the organization on Facebook, X, Instagram, LinkedIn and TikTok.