Julio Chavez, MD from Moffitts Cancer Center & Research Institute speaks about U.S. FDA Approves Yescarta® for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy.
Link to Press Release:
https://www.gilead.com/news-and-press/press-room/press-releases/2021/3/us-fda-approves-yescarta-for-relapsed-or-refractory-follicular-lymphoma-after-two-or-more-lines-of-systemic-therapy
Yescarta® (axicabtagene ciloleucel) has been given accelerated clearance by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy, according to Kite, a Gilead Company. Yescarta is the first chimeric antigen receptor (CAR) T-cell therapy to be accepted for indolent follicular lymphoma patients after FDA Breakthrough Therapy Designation and a priority review. It is also the third approved indication for Kite cell therapy.
The approval is based on the findings of ZUMA-5, a single-arm, open-label trial in which 91 percent of patients with relapsed or refractory FL (n=81) responded to Yescarta, with a reported 74 percent remaining in remission at 18 months (Kaplan-Meier estimate). At a median follow-up of 14.5 months, the median period of response for all FL patients had not been met. Grade 3 or higher cytokine release syndrome (CRS) and neurologic toxicities resulted in 8% and 21% of patients, respectively, in the safety study set (n=146).
Kite Konnect®, an advanced service network that offers information and assistance during the therapy process for Kite’s commercialized CAR T treatments, including courier monitoring for orders and production status alerts, is available to patients whose healthcare providers have recommended Yescarta therapy. Visit www.kitekonnect.com for more information.