In March 2021, the FDA approved a new indication for Yescarta (axicabtagene ciloleucel; from Kite Pharma), a CAR T-cell therapy, for the treatment of patients with relapsed or refractory follicular lymphoma who have received 2 or more lines of systemic therapy.
Yescarta was previously approved for large B-cell lymphoma and was the first CAR T-cell therapy to receive FDA approval. The new approval makes it the first CAR T-cell therapy approved for follicular lymphoma.
The FDA approval was based on the ZUMA-5 clinical trial of 146 patients with relapsed or refractory follicular lymphoma who had received 2 or more lines of therapy.
The overall response rate in 81 evaluable patients was 91%, including 60% complete responses (remissions). The average time to response was 1 month and the 1-year rate of ongoing remissions was 76.2%. In the total of 146 patients, the response rate was 89%, including 62% complete responses.
“Impressively, 91% of follicular lymphoma patients in the ZUMA-5 study responded to a single infusion of axicabtagene ciloleucel,” said Caron A. Jacobson, MD, MMSc, Medical Director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute.
The most common side effects in this study were cytokine release syndrome, fever, hypotension, fatigue, headache, febrile neutropenia, nausea, infection, decreased appetite, chills, diarrhea, tremor, musculoskeletal pain, cough, hypoxia, constipation, vomiting, arrhythmias, and dizziness.