24th April 2025
In recent weeks there have been a number of announcements regarding an alternative treatment option now being available for adults with relapsed/ refractory indolent follicular lymphoma (FL) across the EU and transformed follicular lymphoma within the UK.
The treatment is called lisocabtagene maraleucel, also known as liso-cel (Breyanzi), and is developed by Bristol Myers Squibb. Liso-cel is a type of CAR-T cell therapy, which uses a patient’s own immune cells to fight cancer. The process involves taking T-cells from the patient, modifying them in a laboratory, and then re-infusing them into the body. These engineered cells specifically target and destroy cancer cells, offering potentially powerful ways to combat lymphoma.
In March 2025, the EU expanded the use of liso-cel for adults with relapsed (returned) or refractory (stopped responding) indolent FL, after two or more lines of therapy. This therapy provides an alternative option for those who have not had success with earlier lines of treatments.
Liso-cel is already approved for use as a second-line therapy in patients with more aggressive forms of lymphoma including grade 3b FL (which is treated in the same way as transformed FL), diffuse large B-cell lymphoma, high-grade B‑cell lymphoma and primary mediastinal large B-cell lymphoma.
The EU decision is based on results from a global phase 2 clinical trial called TRANSCEND FL. This study was carried out in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including FL. The results after following patients for up to 3 years were promising: 97% of patients responded to the treatment, and 94% had no detectable cancer after treatment. Many patients continued to show lasting benefits, with nearly 76% still responding after 18 months. Quality of life data was collected throughout the TRANSCEND FL trial, where an improvement in quality of life was seen from as early as 1 month after the start of CAR-T cell therapy and was sustained over time.
The TRANSCEND FL trial included patients with relapsed or refractory grade 1, 2 or 3a FL and another similar cancer, marginal zone lymphoma. Trial patients were required to have received at least one prior treatment before receiving liso-cel. Ahead of administering liso-cel, trial patients first had a round of chemotherapy to prepare their bodies for the infusion. This is known as lymphodepleting chemotherapy, which conditions the immune system to better accept and support the incoming CAR T-cells. The study measured how well the treatment worked and how long the benefits lasted.
In February 2025, NICE (National Institute for Health and Care Excellence) published guidance recommending liso-cel as a treatment option for grade 3b FL (treated in the same way as transformed FL), and other high-grade large B-cell lymphoma patients where:
The CAR-T cell therapy provides an alternative second-line or later option for those with an aggressive form of lymphoma who have not had success with previous lines of therapies or whose cancer has returned within 12 months.
Currently, standard care in the UK for grade 3b or transformed follicular lymphoma in the second-line is usually salvage chemotherapy, high-dose chemotherapy and an autologous stem cell transplant. The evidence supporting the recent NICE recommendation for liso‑cel, comparing against standard care, came from the phase 3 trial TRANSFORM.
Study results showed that liso‑cel increases how long people have before they need another line of treatment, or their condition gets worse, compared with standard care. Evidence for how long people live after treatment with liso‑cel is uncertain, and requires longer follow-up in clinical studies. The trial results also showed liso-cel patients had a better response to treatment than those who received standard care as second-line treatment. The committee at NICE concluded that TRANSFORM demonstrated liso-cel was a more effective second-line treatment compared to standard care, that is safe for people with relapsed/ refractory large B-cell lymphoma – including grade 3b FL.
Regarding safety, liso-cel had side effects similar to other CAR T-cell therapies. The most common side effects of liso-cel, affecting more than 1 in 10 people, include neutropenia (low white blood cell count), anaemia (low red blood cell count), thrombocytopenia (low platelet count), and cytokine release syndrome (a potentially serious condition causing fever, pain, and low blood pressure). Additionally, more than 1 in 10 patients who had two or more prior treatments experienced tiredness.
Overall, liso-cel has shown to be clinically beneficial to patients with relapsed or refractory indolent FL as a third-line or more option, and to patients with the more aggressive grade 3b FL as a second-line option. The side-effects can be serious but generally considered to be manageable, improved compared to other CAR-T cell therapies, and complemented by an improvement in quality of life.
With these recent approvals, liso-cel is now available in the UK, and all European Union countries, as well as Switzerland, Iceland, Norway, and Liechtenstein. The treatment is already approved in the United States and Japan for relapsed/refractory FL, as well as other regions for other types of difficult-to-treat indolent lymphomas.
For more information on “When FL returns or changes” click here, and on immunotherapy options in FL (including CAR-T) click here.
To learn more from the experts and people living with FL who have received CAR-T therapy, experienced relapse and for more information on clinical trials, watch our webinars on these important topics.
– BMS press-release about EU approval: Bristol Myers Squibb – Bristol Myers Squibb Receives Approval from the European Commission to Expand Use of CAR T Cell Therapy Breyanzi for Relapsed or Refractory Follicular Lymphoma
– NICE approval in the UK: Information for the public | Lisocabtagene maraleucel for treating relapsed or refractory large B-cell lymphoma after first-line chemoimmunotherapy when a stem cell transplant is suitable | Guidance | NICE
– FDA approval in the US: FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma | FDA
This article is for information purposes only, and we recommend that you speak with your healthcare team if you have any questions around suitability and regional accessibility of therapy options.
If you have any questions, please get in touch by emailing us at info@theflf.org
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