FDA approves new CAR T-Cell therapy production process

The US Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter time to market for Gilead Kite's production of the Yescarta CAR T-cell therapy.

With this approval, the median turnaround time in the US is anticipated to be reduced from 16 to 14 days. Median turn-around time 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 customised 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.”


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