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FDA Approves Gilead's Yescarta as Second-Line Treatment for Large B-Cell Lymphoma Patients

NEW YORK – The US Food and Drug Administration on Friday approved Gilead Sciences' autologous CAR T-cell therapy Yescarta (axicabtagene ciloleucel) as a second-line treatment for large B-cell lymphoma (LBCL) patients within a year of receiving first-line therapy.

The news marks the first time the FDA has approved a CAR T-cell therapy for LBCL patients in this earlier treatment setting. The agency had previously approved Yescarta as a later-line LBCL treatment after patients had received intensive therapy.

Regulators decided to approve the second-line indication based on data from the randomized Phase III ZUMA-7 study, in which 359 relapsed or refractory LBCL patients received either a single infusion of Yescarta or a standard-of-care regimen consisting of high-dose chemotherapy followed by a stem cell transplant.

After more than two years of follow-up, the median event-free survival time was 8.3 months for patients on Yescarta and 2 months for patients on standard treatment. Event-free survival is defined as the time between randomization and disease progression, receipt of a new line of therapy, or death by any cause. The two-year event-free survival rates were 40.5 percent with Yescarta and 16.3 percent with standard-of-care treatment.

The National Comprehensive Cancer Network also updated its LBCL guidelines to include Yescarta for this patient population as a Category 1 treatment recommendation, signaling unform, expert consensus based on high-level evidence.

"Today's approval marks an exciting new standard of care," Frederick Locke, co-leader of Moffitt Cancer Center's immuno-oncology program and principal investigator of the ZUMA-7 trial, said in a statement. He added that the field has now "amassed significant experience with CAR T-cell therapy to better manage or prevent side-effects, making [Yescarta] more accessible for older patients and those with medical conditions for whom the standard of care might be difficult."

According to a statement from Gilead, regulators around the world are also reviewing Yescarta for potential approval in additional indications including the patient population in ZUMA-7.