Yescarta Follicular Lymphoma EMA Approved the Listing on June 28, 2022
Yescarta Follicular Lymphoma EMA Approved the Listing on June 28, 2022
Yescarta Approved in the European Union for Follicular Lymphoma
On June 28, 2022, local time, Gilead’s cell therapy company Kite Pharma announced that the European Commission (EC) has approved its CAR-T cell therapy Yescarta® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. Previously, in March 2021, the FDA approved Yescarta for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, and Yescarta was the first CAR-T cell therapy approved for the treatment of FL.
Data Supporting Yescarta’s Approval
This approval of the CAR-T cell therapy Yescarta was based on data from the pivotal single-arm Phase 2 ZUMA-5 (NCT03105336) international study, which evaluated 122 adult patients (≥18 years) with R/RFL. The study enrolled patients with relapsed or refractory follicular lymphoma (FL) who had received at least two prior lines of systemic therapy, including an anti-CD20 monoclonal antibody and an alkylating agent. In patients who had received three or more lines of therapy (n=75), the data showed an overall response rate (ORR) of 91% and a complete response rate (CR) of 77% at a median follow-up of 24 months. The median duration of response (DOR) was 38.6 months, with a 24-month ongoing response rate of 56%.
In all evaluable patients (n=119) in the ZUMA-5 study, the safety observations were consistent with the known safety profile of Yescarta. The incidence of Grade ≥3 cytokine release syndrome (CRS) was 6%, and 16% of patients experienced neurological events. These data are clinically significant.
Expert Evaluation
Kite Chief Executive Officer Christi Shaw said, “Patients with relapsed or refractory follicular lymphoma in later lines of treatment are in desperate need of new therapeutic options, and this new indication approval represents Kite’s third indication for a cell therapy product in Europe. We are pleased to be able to offer this innovative therapy to more patients across different types of lymphoma.”
Ibrahim Yakoub-Agha, Head of the Cell Therapy Unit at the University Hospital of Lille, France, said, “Multiply relapsed follicular lymphoma is a difficult-to-treat disease with a particularly poor prognosis, with only 20% of patients surviving five years after their second relapse. In the ZUMA-5 study, 91% of patients responded to Yescarta after receiving three or more prior therapies, with more than half of patients still responding at two years. These signs of durable remission are critically important for patients in need of a therapy that can provide long-term benefit.”