Yescarta Receives Follicular Lymphoma Indication

March 5, 2021 – The U.S. FDA has approved a new indication for Yescarta® (axicabtagene ciloleucel), manufactured by Gilead, to treat relapsed or refractory follicular lymphoma (FL) in adults who have had at least two prior lines of systemic therapy. Yescarta is one of only four chimeric antigen receptor T-cell (CAR-T) therapies approved for use in the United States. It is the first to receive FDA approval to treat FL.

FL is an indolent (slow growing) form of non-Hodgkin lymphoma (NHL). It is the most common type of indolent lymphoma and accounts for 22% of all lymphoma cases globally – making it the second most common lymphoma worldwide. Because of its typically slow progression, FL is often considered a chronic disease. Patients can live many years with an FL diagnosis. However, the five-year survival rate for patients whose disease has returned after two prior lines of therapy is only 20%. Treatment options for this patient population are limited.

In a clinical study, 91% of FL patients achieved complete or partial remission of disease following treatment with Yescarta. An estimated 74% of patients remained in remission at 18 months. Like other CAR-T therapies, Yescarta treats cancer using the patient’s own immune system. A laboratory modifies a collection of the patient’s T cells – a type of white blood cell – to improve the cells’ ability to identify and attack cancer cells in the body. The modified T cells are administered to the patient as a one-time intravenous infusion.

Yescarta is only available through a Risk Evaluation and Mitigation Strategy (REMS) program. A black box warning cautions that the treatment can cause potentially life-threatening neurological toxicity and cytokine release syndrome.

First FDA approved in 2017, Yescarta is also indicated to treat large B-cell lymphoma.