FDA Approves Manufacturing Process Change For Kite Pharma’s Yescarta

The U.S. Food and Drug Administration (FDA) has approved a manufacturing process change for Kite Pharma (a Gilead Company) resulting in a shorter manufacturing time for Yescarta (axicabtagene ciloleucel).
With this approval, Kite’s median turnaround time (TAT) in the U.S. is anticipated to be reduced from 16 days to 14 days.
Median TAT is defined as time from leukapheresis, when a patient’s T cells are collected, to product release; manufacturing is a key step within this process to prepare a patient’s cells for a one-time cell therapy infusion customized for each patient.

Shortening Delivery Time and Increasing Possible Chance of Survival

“For patients with relapsed or refractory large B-cell lymphoma, every day matters as the patient’s disease can be aggressive and worsen rapidly,” said Cindy Perettie, Executive Vice President, Kite. “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.”
Industry experts agree that shortening the time to Yescarta product release and delivery can allow healthcare providers at Kite Authorized Treatment Centers to better support their patients.
“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,” said David Miklos, MD, PhD, a Kite clinical investigator/Chief of Blood and Marrow Transplant and Cell Therapy at Stanford University. “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.”
Kite has continued to increase its manufacturing network capacity to meet growing demand, ensuring scheduling availability to meet the needs of physicians and their patients.

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Kite and Arcellx recently expanded the scope of their existing collaboration for CART-ddBCMA to include lymphomas.


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