Liso-cel CAR T-Cell Therapy Receives FDA Approval for Follicular Lymphoma

Follicular lymphoma is the second most common type of non-Hodgkin lymphoma (NHL), diagnosed in around 14,000 new people each year in the US. While treatment options exist, the disease can sometimes return after treatment (relapse) or become resistant to therapy (refractory). On May 15, 2024, the FDA approved a new treatment option called lisocabtagene maraleucel or liso-cel (marketed as Breyanzi by Bristol Myers Squibb) for adults with relapsed or refractory follicular lymphoma. 

What is Liso-cel?

Liso-cel is a CAR T-cell therapy. CAR stands for Chimeric Antigen Receptor. CAR T-cell therapy involves taking a patient's T cells, a white blood cell important for fighting infection, and modifying them in a lab to recognize and attack cancer cells. In the case of liso-cel, the modified T cells are designed to target a specific protein (CD19) found on the surface of follicular lymphoma cells.

Liso-cel has been granted an FDA accelerated approval, which allows the product to be commercially available for patients while continuing to monitor long-term outcomes in larger clinical trials. 

Within the last three years, liso-cel has been approved in the US to treat patients with large B cell lymphoma, chronic lymphocytic leukemia (or small lymphocytic lymphoma), and now relapsed follicular lymphoma after two or more kinds of treatment have not worked or stopped working.

What is Important to Know About Liso-cel?

It's important to note that liso-cel is a complex treatment with specific criteria for eligibility. Here are some key things to consider:

• Liso-cel is for adults with relapsed or refractory follicular lymphoma. This means it's typically not used as a first-line treatment but may be an option if the lymphoma has come back after other treatments or has not responded well to previous therapies.
• Liso-cel CAR T-cell therapy is a one-time infusion. The modified T cells are given through an intravenous (IV) line.
• Clinical trials have shown promising results in relapsed or refractory follicular lymphoma. Studies have indicated that liso-cel can induce a significant reduction of the disease in 97% of patients, with 81.9% of responders still in response one year after the infusion.  
• Liso-cel can have serious side effects. CAR T-cell therapy can cause serious side effects, including cytokine release syndrome (CRS) and neurologic toxicities. With liso-cel, 53% of patients experienced CRS, and 31% neurologic side effects, although they were majoritarily mild. These side effects require close monitoring and management by a healthcare team experienced in administering CAR T-cell therapies.

CAR-T Therapies Approved to Treat Follicular Lymphoma

Liso-cell joins two other FDA-approved CAR-T therapies for follicular lymphoma: axicabtagene ciloleucel (axi-cel, Yescarta) and tisagenlecleucel (tisa-cel, Kymriah). All three treatments target a protein called CD19 present on lymphoma cells, and have reported high rates of cancer remission with only one infusion. However, they have different safety considerations, and some patients may respond better to one over the others. It's important to consult your doctor to understand which CAR-T therapy might be the best fit for your specific situation.

Liso-cel represents a significant advancement in treatment options for adults with relapsed or refractory follicular lymphoma. Stay updated with the rapid developments in follicular lymphoma research by signing up for the HealthTree Newsletter: 

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Sources: 

• FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma
• Bristol Myers Squibb’s CAR T Cell Therapy Breyanzi Approved by the U.S. Food and Drug Administration for Relapsed or Refractory Follicular Lymphoma
• Cell Therapy 360. End-to-End Support for Bristol Myers Squibb CAR T Cell Therapies