A New CAR T-Cell Therapy for Large B-Cell Lymphoma Receives FDA Approval
On 5 February 2021, the US Food and Drug Administration (FDA) approved a living cancer drug to treat adult patients with diffuse large B-cell lymphoma subtypes that had not responded to or had relapsed after at least two prior lines of treatment. This cell-based gene therapy is called lisocabtagene maraleucel (Breyanzi, Juno Therapeutics). This is the 3rd CAR T-cell therapy approval granted by the FDA.
A chimeric antigen receptor (CAR) T-cell therapy, Breyanzi is the third gene-editing therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). Breyanzi is not indicated for treating patients with primary central nervous system lymphoma.
This cellular therapy approval represents another milestone in the rapidly advancing field of gene therapy, offering an additional treatment option for adults with certain cancers affecting the blood, bone marrow and lymph nodes. Gene and cell therapies once excited us as promising concepts; now they have become feasible, approved cancer treatments.
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in adults. Non-Hodgkin lymphomas are cancers that begin in certain cells of the immune system and may grow rapidly (aggressively) or slowly. Every year, 6,200 new cases of non-Hodgkin lymphoma are diagnosed in Türkiye and approximately 77,000 in the USA, and DLBCL accounts for about one in three newly diagnosed cases.
Breyanzi is a customized treatment created using the patient's own T cells (a type of white blood cell) to help fight lymphoma. The patient's T cells are collected and genetically modified to contain a new gene that facilitates targeting and killing lymphoma cells. After the cells are modified, they are given back to the patient.
The safety and efficacy of Breyanzi were demonstrated in a multicentre clinical trial in patients with treatment-resistant or relapsed large B-cell lymphoma, involving more than 250 adults.
The complete remission rate after treatment with Breyanzi was 54%.
Treatment with Breyanzi has the potential to cause serious side effects. The prescribing information carries a boxed warning for cytokine release syndrome (CRS), a systemic response to the activation and proliferation of CAR T cells that causes high fever and flu-like symptoms, and for neurological toxicities. Both cytokine release syndrome and neurological events can be life-threatening. Other side effects include hypersensitivity reactions, serious infections, low blood cell counts and a weakened immune system. Side effects generally appear within the first one to two weeks after treatment, but some may occur later.
Because of the risk of CRS and neurological toxicity, Breyanzi is approved with a risk evaluation and mitigation strategy containing elements to assure safe use. Among other requirements, the FDA requires healthcare facilities administering Breyanzi to be specially certified. As part of this certification, personnel involved in prescribing, dispensing or administering Breyanzi must be trained to recognize and manage the risks of CRS and neurological toxicities.
To further assess long-term safety, the FDA also requires the manufacturer to conduct a postmarketing observational study involving patients treated with Breyanzi.
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