FDA Approves Kite’s Axi-Cel Manufacturing Change to Reduce Turnaround Time

David Miklos, MD, PhD

The FDA has approved Kite Pharma’s manufacturing process change for axicabtagene ciloleucel (axi-cel; Yescarta). The new change is expected to reduce median turnaround time from leukapheresis to product release from 16 days to 14 days.¹

“For patients with relapsed or refractory large B-cell lymphoma (LBCL), every day matters as the patient’s disease can be aggressive and worsen rapidly,” Cindy Perettie, Executive Vice President, Kite, said in a statement.¹ “Yescarta is the first and only treatment to demonstrate superior overall survival over the standard of care as a second-line treatment with curative intent for these patients, and today’s decision by the FDA allows us to further shorten our delivery time of Yescarta so that patients have the best possible chance of survival.”

Time to treatment is an important factor in improving outcomes for patients receiving CAR T-cell therapy. Kite stated in its release that it is continuing to increase its manufacturing network capacity to meet the growing demand for axi-cel.

“Since the first CAR T-cell therapies were approved more than five years ago and the volume of patients treated has grown from hundreds to several thousand patients each year, we have significantly strengthened our knowledge and understanding of cell therapy delivery,” clinical investigator David Miklos, MD, PhD, Chief, Blood and Marrow Transplant and Cell Therapy, Stanford University, added.¹ “Time is a critical factor in cell therapy, and it can make the difference between a patient being able to receive CAR T or their cancer progressing to the point where they are no longer strong enough for treatment. Therefore, optimizing steps in the process and ultimately reducing the time to CAR T-cell therapy infusion is paramount.”

WATCH NOW: Jay Spiegel, MD, FRCPC, on 5-Year Real-World Outcomes From Axi-cel in R/R LBCL

Axi-cel was approved for the second-line treatment of LBCL in April 2022, for adult patients with disease refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.²

“Given that each cell therapy batch is unique to each patient, manufacturing is central to how we deliver our therapies, and quality, reliability, and speed are critical,” Chris McDonald, senior vice president, Global Head of Technical Operations, Kite, added.2 “As the global leader in cell therapy, patients and physicians count on our 96% manufacturing success rate, and with a reduced manufacturing time in the U.S., we will continue to expand the reach of Yescarta to even more patients.”

In other efforts to improve manufacturing efficiency and costs, Kyverna Therapeutics recently published data on its proprietary CAR T-cell vein-to-vein manufacturing process, Ingenui-T. The process utilizes less than 300 ml of whole blood from a blood draw instead of apheresis for the collection of T cells from patients undergoing CAR T-cell therapy. Apheresis is usually performed via leukapharesis, which requires patients to be connected to a cell separator at specialized centers for up to 5 hours. Unlike Kite, Kyverna is developing CAR T-cell therapies for treating autoimmune diseases.³

"Ingenui-T represents the culmination of significant development work and our commitment to improve the patient journey and current industry-standard processes for CAR T-cell therapies by easing the burden on patients and improving outcomes," Karen Walker, chief technology officer, Kyverna, said in a statement.³ "We were able to achieve a process minimization without compromising the quality of the operations or the characteristics of the resulting product."

REFERENCES

1. Kite Receives U.S. FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta® CAR T-cell Therapy. News release. Kite Pharma. January 30, 2024.https://www.gilead.com/news-and-press/press-room/press-releases/2024/1/kite-receives-us-fda-approval-of-manufacturing-process-change-resulting-in-reduced-median-turnaround-time-for-yescarta-car-tcell-therapy
2. FDA approves axicabtagene ciloleucel for second-line treatment of large B-cell lymphoma. News release. FDA. April 1, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-axicabtagene-ciloleucel-second-line-treatment-large-b-cell-lymphoma
2. Kyverna Therapeutics announces first publication of Ingenui-T, a novel CAR T-cell vein-to-vein manufacturing process. News release. January 24, 2024. https://www.prnewswire.com/news-releases/kyverna-therapeutics-announces-first-publication-of-ingenui-t-a-novel-car-t-cell-vein-to-vein-manufacturing-process-302043859.html