FDA Approves Manufacturing Process Change for Kite Pharma’s Yescarta

With this approval, Kite’s median turnaround time (TAT) in the U.S. is anticipated to be reduced from 16 days to 14 days.

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By: Charlie Sternberg

Associate Editor

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 prep...

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