FDA approves manufacturing process change for Kite’s Yescarta for TAT reduction

Kite, a Gilead Company announced that the U.S. Food and Drug Administration FDA has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta or 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. “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.”..Kite has continued to increase its manufacturing network capacity to meet growing demand, ensuring scheduling availability