FDA approves Yescarta for relapsed/refractory follicular lymphoma
The U.S. Food and Drug Administration granted accelerated approval to Yescarta (axicabtagene ciloleucel; Kite) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after ≥2 lines of systemic therapy, according to a press release. This is the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent FL.
Approval is based on results from the single-arm, open-label study which found 91% of participants with relapsed or refractory FL responded to axicabtagene ciloleucel. Kaplan-Meier estimation was 74% of patients in a continued remission at 18 months.
“Once a follicular lymphoma patient’s disease relapses, the duration of response to care shortens with each round of therapy,” 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, in a press release. “Additionally, for follicular patients in the third line of therapy, the five-year survival rate is only 20 percent, highlighting the urgent need for treatments that offer a real chance for durable remission. Impressively, 91 percent of follicular lymphoma patients in the ZUMA-5 study responded to a single infusion of axicabtagene ciloleucel, including an estimated 74 percent of patients in a continued remission at 18 months, giving these patients much-needed hope and oncologists an important addition to the treatment armamentarium.”
Read the full press release here.