Gilead's Kite announced that the U.S. FDA has granted accelerated approval to Yescarta for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Follicular lymphoma (FL) is a form of indolent non-Hodgkin lymphoma in which malignant tumors slowly grow but can become more aggressive over time. Kite's chimeric antigen receptor (CAR) T-cell therapy is a first-of-its-kind treatment for adult patients with indolent follicular lymphoma.
The FDA's decision was based on ZUMA-5, a single-arm, open-label study, that demonstrated 91% of patients with relapsed or refractory FL responded to Yescarta.
The agency included a boxed warning on the label for cytokine release syndrome and neurologic toxicities.
Yescarta was previously approved for use in relapsed or refractory large B-cell lymphoma in 2017, shortly after Gilead acquired the treatment in a $12 billion Kite Pharma buyout.
Read the press release
