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FDA Approves Axi-Cel as Initial Treatment for Relapsed, Refractory LBCL

APPROVED

The U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (axi-cel) CAR T-cell therapy for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapsed within 12 months of first-line treatment.

The approval was based on the results of the ZUMA-7 trial that randomly assigned 359 patients with relapsed or refractory LBCL within 12 months of first-line therapy to a single infusion of axi-cel or current standard of care second-line therapy.

Axi-cel demonstrated a clinically meaningful and statistically significant improvement in event-free survival compared with the current standard of care (hazard ratio=0.398;P<.0001). At 2 years, 2.5 times more patients that received axi-cel were without disease progression or need for additional treatment compared with standard of care (40.5% vs. 16.3%). Median event-free survival was 8.3 months with axi-cel compared with 2.0 months with standard of care.

Commenting on the approval, Frederick L. Locke, MD, a principal investigator on ZUMA-7 and Co-Leader of the Immuno-Oncology Program at Moffitt Cancer Center, Tampa, Florida said that the approval marks a new standard of care for patients.

The ZUMA-7 trial enabled us to look at the broader picture of what happens to patients after a decision is made to follow a particular treatment path,” Dr. Locke said in a prepared statement. “What we found was that axi-cel resulted in three times as many patients receiving treatment with curative intent (CAR T-cell therapy), and an overall better outcome for patients than the previous standard of care.

Dr. Locke presented the results of ZUMA-7 at the Plenary session of the American Society of Hematology’s Annual Meeting & Exposition in December.

The National Comprehensive Cancer Center recently updated is guidelines for B-cell lymphomas to recommend axi-cel for this patient population as a Category 1 recommendation.

Source: Gilead Press Release, April 2022

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