Kite seeks expanded approval of Yescarta for large B-cell lymphoma
Kite Pharma submitted a supplemental biologics license application to the FDA that seeks expanded approval of axicabtagene ciloleucel.
Axicabtagene ciloleucel (Yescarta, Kite Pharma), a CD19-directed genetically modified autologous T-cell immunotherapy, is approved in the United States for adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma who received two or more lines of therapy.
The supplemental biologics license application seeks approval of axicabtagene ciloleucel — often called axi-cel — in the second-line setting for adults with relapsed or refractory large B-cell lymphoma.
If approved, axi-cel would be the first chimeric antigen receptor T-cell therapy for adults with large B-cell lymphoma who relapsed after or were refractory to first-line therapy.
The application is based on results of the randomized phase 3 ZUMA-7 study, which included 359 patients with relapsed or refractory large B-cell lymphoma.
Researchers assigned patients to axi-cel or standard of care for second-line therapy. Standard care consisted of platinum-based salvage combination chemotherapy, followed by high-dose therapy and autologous stem cell transplant for those who respond to salvage chemotherapy.
EFS served as the primary endpoint. Secondary endpoints included objective response rate and OS.
Median follow-up was 2 years.
As Healio previously reported, results showed axi-cel significantly extended EFS compared with standard of care (HR = 0.39; P < .0001). Axi-cel also appeared associated with a higher ORR. OS data remained immature at the time of analysis.
Complete results of ZUMA-7 have been submitted for presentation at a medical meeting.
“Yescarta demonstrated an impressive clinical benefit over the current standard of care in the ZUMA-7 study, and these findings highlight the potential of this transformative therapy to help even more patients,” Frank Neumann, MD, PhD, global had of clinical development for Kite Pharma, said in a Kite Pharma-issued press release. “Approximately 40% of adult patients diagnosed with [large B-cell lymphoma] require second-line treatment, and we are committed to working with the FDA to provide a new treatment option for these patients.”