Yescarta Accelerated Approval for Follicular Lymphoma

FDA has granted Kite accelerated approval for Yescarta (axicabtagene ciloleucel) for treating adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Yescarta is the first chimeric antigen receptor T-cell therapy approved for patients with indolent FL, the company says.

The approval is based on results from the ZUMA-5 trial, a single-arm, open-label study in which 91% of patients with relapsed or refractory FL (n=81) responded to Yescarta, including 74% percent of patients in continued remission at 18 months, Kite says. (Kaplan-Meier estimate). “Among all FL patients, median duration of response was not reached at a median follow-up of 14.5 months. In the safety analysis set (n=146), Grade 3 or higher cytokine release syndrome (CRS) and neurologic toxicities occurred in 8% and 21% of patients, respectively,” it says.