FDA Approves Kite’s Manufacturing Process Change, Leading to Faster Turnaround Time for Yescarta CAR T-cell Therapy

Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change 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.

“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.”

CAR T-cell therapies are one-time treatments individually made starting from a patient’s own white blood cells, called T-cells. The cells are removed through leukapheresis and sent to Kite’s specialized manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR). Once an individual therapy is created for a patient, the cells are carefully checked, preserved, packed and sent back to the hospital to be infused back into the patient. The CAR T-cell therapy process is a continuous one, from leukapheresis to the delivery of the final product, so the timing and scheduling of this process are critical to the supply. To see how this process works, please click here.

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.”

Stanford is one of Kite’s more than 135 authorized treatment centers (ATCs) in the U.S. and more than 400 total across the world.

More than 17,700 patients have been treated with Kite’s CAR T-cell therapies through these ATCs across the globe. Kite has taken a unique approach to scaling the technology of cell therapy, combining capacity, speed, and reliability and the largest in-house cell therapy manufacturing network in the world to rapidly deliver products to these authorized treatment centers.

“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,” said Chris McDonald, SVP, Global Head of Technical Operations, Kite. “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.”

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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