FDA Clears Axi-Cel for Relapsed/Refractory Indolent Follicular Lymphoma

The FDA Friday approved axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory follicular lymphoma following 2 or more lines of systemic therapy.

The decision was based on data from the phase 2 ZUMA-5 trial (NCT03105336), in which the chimeric antigen receptor (CAR) T-cell treatment elicited a response in 91% of patients with relapsed or refractory follicular lymphoma (n = 81); 74% of patients had a continued remission at 18 months.

Among all patients with follicular lymphoma, the median duration of response was not reached at a median follow-up of 14.5 months.

In the safety analysis conducted in 146 patients, grade 3 or higher cytokine release syndrome and neurologic adverse effects were reported in 8% and 21% of patients, respectively.

In a statement late Friday, Kite, a Gilead company, said the approval marks the first CAR T-cell therapy approved for patients with indolent follicular lymphoma, follows FDA Breakthrough Therapy Designation and a priority review, as well as the third approved indication for a Kite cell therapy.

For these patients in the third line of therapy, the 5-year survival rate is only 20%, said Caron A. Jacobson, MD, MMSc, Medical Director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute and Assistant Professor of Medicine, Harvard Medical School.