A New Immunotherapy Option for Follicular Lymphoma 

The FDA granted accelerated approval to a CAR T-cell therapy for certain adult patients with follicular lymphoma.  

The U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel (Kymriah) for certain adult patients with relapsed or refractory follicular lymphoma who previously underwent two or more lines of anticancer therapy.  

Tisagenlecleucel is a chimeric antigen receptor (CAR) T-cell therapy, a form of immunotherapy that involves genetically engineering a patient’s own T cells and infusing them back into the body to treat the cancer. Tisagenlecleucel targets cancer cells that express the CD19 protein. 

The approval was based on the multicenter, single-arm, open-label ELARA phase II clinical trial conducted in adult patients whose disease did not respond to or relapsed after two or more lines of systemic therapy, or relapsed after autologous hematopoietic stem cell transplant. Prior to receiving treatment with tisagenlecleucel, participants received chemotherapy to reduce the number of natural T-cells and keep them from interfering with the function of the CAR T cells.    

Among the 90 patients included in the analysis, the overall response rate was 86 percent with a complete response rate of 68 percent. The median duration of response was not reached, and 75 percent of patients whose disease responded to therapy were still experiencing a response after nine months.  

Follicular lymphoma is a slow-growing form of non-Hodgkin lymphoma that arises from B lymphocytes. According to federal statistics, 80,470 new cases of non-Hodgkin lymphoma will be diagnosed in the U.S. in 2022, and follicular lymphoma is estimated to account for approximately 20 percent of non-Hodgkin lymphoma cases. 

The FDA rendered its decision on May 27, 2022. Accelerated approval means continued approval may be contingent upon a confirmatory trial.