On March 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to axicabtagene ciloleucel (axi-cel) for the treatment of relapsed/refractory follicular lymphoma (FL) following two or more lines of therapy.
Axi-cel, developed by Gilead subsidiary Kite Pharma and sold commercially as Yescarta, is a chimeric antigen receptor (CAR) T-cell therapy previously approved for the treatment of relapsed/refractory large B-cell lymphoma. It is the first CAR T-cell therapy approved for FL.
“As we look to bring the hope of survival to more patients in need, today’s FDA decision represents a real step forward in our commitment in hematologic malignancies,” said Christi Shaw, Chief Executive Officer of Kite, in a press release. “Advancing CAR T therapies for patients across lymphomas remains a cornerstone of our cell therapy development program, and we are excited about the potential of Yescarta for patients with indolent FL.”
The approval is supported by data from the multicenter ZUMA-5 study, which evaluated the efficacy and safety of axi-cel in 81 patients with FL. Overall, 91% of patients responded to a single infusion of axi-cel, with 60% achieving a complete response. Median duration of response has yet to be reached in the study cohort.
The most common grade 3 or higher adverse events, occurring in more than 10% of patients, includes febrile neutropenia, encephalopathy, and infection. The treatment comes with a boxed warning for risks of cytokine release syndrome and neurologic toxicities.
:: FDA Update:: @US_FDA approves axicabtagene ciloeucel (YESCARTA, Kite, a Gilead Company) for adult patients with relapsed or refractory follicular lymphoma after at least two lines of systemic therapy. Read more about this approval: https://t.co/lOVwTxx2Ie
— Lymphoma Research Foundation (@lymphoma) March 8, 2021
#NEWS: We are pleased to announce the @US_FDA has granted accelerated approval to our #CARTcell therapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
— Kite, a Gilead Company (@KitePharma) March 6, 2021