Kite Receives FDA Approval for Manufacturing Process Change for Yescarta
1 February 2024
The FDA has approved a manufacturing process change, resulting in a shorter manufacturing time for Yescarta. The new anticipated median turnaround time is reduced from 16 days to 14 days.
Kite, a Gilead Company, has received FDA approval for a manufacturing process change that will reduce the median turnaround time (TAT) for Yescarta® (axicabtagene ciloleucel) in the U.S. from 16 to 14 days. This modification, crucial for patients undergoing CAR-T cell therapy, is expected to optimize the process and shorten the time from leukapheresis to product release.
Cindy Perettie, Executive Vice President at Kite, said,
“Today’s FDA decision allows us to further expedite Yescarta’s delivery, increasing the chance of survival for patients.”
CAR-T cell therapies involve a one-time treatment process where T cells are collected through leukapheresis, modified with a Chimeric Antigen Receptor (CAR), and then infused back into the patient. This streamlined manufacturing process not only enhances the supply chain but also enables healthcare providers at Kite Authorized Treatment Centers to better support patients.
Dr. David Miklos, a Kite clinical investigator and Chief of Blood and Marrow Transplant and Cell Therapy at Stanford University, commented on the critical nature of time in cell therapy, stating:
“Optimizing steps in the process and ultimately reducing the time to CAR-T cell therapy infusion is paramount.”
Kite, with over 135 authorized treatment centers in the U.S. and more than 400 worldwide, has successfully treated over 17,700 patients with its CAR-T cell therapies. The company’s commitment to quality, reliability, and speed, reflected in its 96% manufacturing success rate, aligns with its goal to expand the reach of Yescarta to more patients.
Chris McDonald, SVP, Global Head of Technical Operations at Kite, highlighted:
“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.”
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