Label Update for Axi-Cel Approved by US FDA After ZUMA-7

The FDA has approved a label update for axi-cel (Yescarta) based on results from the phase III ZUMA-7 study that showed axi-cel significantly improved OS compared with standard of care in patients with relapsed or refractory large B-cell lymphoma (LBCL).

Axi-cel, sold under the trade name Yescarta, is an autologous CAR T-cell therapy used as a potentially curative second-line treatment for LBCL within 12 months of first-line therapy completion.

“Our ZUMA-7 overall survival analysis proves that when given as second-line therapy, Yescarta is even more effective in improving patient survival than standard-of-care treatment. Coupled with our rapid and reliable manufacturing, it is our hope to provide patients a chance to live longer lives,” said Frank Neumann, MD, PhD, the Senior Vice President and Global Head of Clinical Development at Kite Pharma, the manufacturer of the drug.

Standard-of-care therapy for relapsed or refractory LBCL conventionally includes chemoimmunotherapy that, if successful, is followed by high-dose chemotherapy and autologous hematopoietic stem cell transplantation (HSCT).

Less than 40% of patients who begin the process actually undergo HSCT, according to a press release from Kite, whereas 94% of patients who received a one-time infusion of axi-cel in ZUMA-7 went on to complete transplantation.

Axi-cel is the “first and only treatment in nearly 30 years” to yield improved survival in patients with relapsed or refractory LBCL in the second-line setting, the release concluded.