FDA Approves New Process to Accelerate CAR T-Cell Therapy Manufacturing

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The FDA has approved a manufacturing process change that will result in a shorter manufacturing time for Yescarta, Kite’s branded form of axicabtagene ciloleucel. As a result, Kite’s median turnaround time (TAT) in the United States is projected to decrease from 16 days to 14 days.

According to Gilead, who acquired Kite back in 2017, median TAT is the time from leukapheresis when a patient’s own white blood cells, or T cells, are collected, to product release. The manufacturing process is vital in preparing a patient’s cells for a one-time cell therapy infusion that is specifically tailored to meet each patient’s needs.

Once the cells are removed via leukapheresis and sent to Kite’s specialized manufacturing facilities, they are then modified with a chimeric antigen receptor (CAR). After they are checked, preserved, and packed, the cells are shipped back to the hospital to be infused back into the patient.

“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,” says David Miklos, MD, PhD, a Kite clinical investigator/chief of blood and marrow transplant and cell therapy at Stanford University, which is one of Kite’s authorized treatment centers. “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.”

Reference

Kite Receives US FDA Approval of Manufacturing Process Change Resulting in Reduced Median Turnaround Time for Yescarta CAR T-cell Therapy. Gilead. January 30, 2024. Accessed January 31, 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