According to a story from Pharmacy Times, the US Food and Drug Administration (FDA) has approved a new treatment for large B-cell lymphoma that is relapsed or refractory. Refractory means that the cancer has become resistant to treatment. The new treatment, called lisocabtagene maraleucel (marketed as Breyanzi), is a chimeric antigen receptor (CAR) T-cell therapy that is CD19-directed.
About Large B-Cell Lymphoma
Large B-cell lymphoma (LBCL), as the name suggests, is a cancer that affects B cells, which are a type of white blood cell. These cells are responsible for producing antibodies. There is a diverse array of different variants and subtypes of this cancer, and it is the most common form of non-Hodgkin’s lymphoma in adults. Although it can occur in children and young adults in the rarest cases, this type of lymphoma primarily affects older people, usually around 70 or older. Symptoms are typical of many lymphomas, and include night sweats, fatigue, unexpected weight loss, a noticeable mass in the lymph nodes, and fever. Risk factors include underlying immunodeficiencies and infection from the Epstein-Barr virus and Helicobacter pylori. Occasionally, this lymphoma can transform from other types of blood cancer. Treatment includes chemotherapy, rituximab, stem cell transplantation, and immunotherapy; the five year survival rate is 58 percent. To learn more about large B-cell lymphoma, click here.
With consideration to the many forms of this lymphoma, Breyanzi is approved for several different variants, such as non-specified diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, grade 3B follicular lymphoma, and high-grade B-cell lymphoma. It is intended for those patients who have been previously treated with at least two other systemic therapies.
The approval follows results from a clinical trial in which a total of 268 patients were treated with Breyanzi. 73 percent of patients that were treated achieved a clinical response; this included 19 percent who saw a partial response and 54 percent who had minimal or no detectable disease following the treatment course. The median response duration for treated patients was 16.7 months. As in other CAR T-cell therapies, adverse effects were prevalent, and 46 percent of patients experienced serious adverse effects; 4 percent of patients experienced fatal adverse effects.
The approval of Breyanzi offers a new therapeutic option for patients who are not responding to other treatment approaches and are facing disease that is relapsed.