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Gilead Files for FDA Approval of Second-Line Yescarta for Large B-Cell Lymphoma

NEW YORK – Gilead subsidiary Kite on Thursday said that it has submitted an application to the US Food and Drug Administration for its autologous CAR T-cell therapy, axicabtagene ciloleucel (Yescarta) for second-line large B-cell lymphoma treatment.

Axicabtagene ciloleucel, or axi-cel, is currently approved for relapsed or refractory LBCL patients after two or more prior therapies. If FDA approves the drugmaker's supplemental biologics application, axi-cel would be the first CAR T-cell therapy available for these patients in the earlier, second-line treatment setting.

With its FDA submission, Kite has included two-year follow-up data from the Phase III ZUMA-7 study, which pitted axi-cel against standard-of-care therapy for this patient population. In the trial, Kite randomly assigned nearly 360 patients with relapsed or refractory LBCL to either a one-time infusion of axi-cel or the current standard of care, which involves chemotherapy followed by a stem cell transplant contingent on chemotherapy responses.

According to Kite, the study met its primary endpoint of prolonging event-free survival in this patient population, reducing the risk of disease-free progression by 60 percent versus the standard-of-care regimen. While it is too soon for the firm to report overall survival data from the trial, Kite said that the CAR T-cell therapy also met its secondary endpoint of improved objective response rates.

Kite, which is also in the midst of discussions with health authorities in other countries to expand axi-cel's indication to the second-line setting, plans to present ZUMA-7 results at an upcoming medical conference.

"[ZUMA-7] findings highlight the potential of this transformative therapy to help even more patients," Frank Neumann, Kite's global head of clinical development, said in a statement. "Approximately 40 percent of adult patients diagnosed with LBCL require second-line treatment, and we are committed to working with the FDA to provide a new treatment option for these patients."