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FDA Approves Shorter Manufacturing Time for Axi-Cel

By Melissa Badamo - Last Updated: February 7, 2024

The US Food and Drug Administration (FDA) has approved a manufacturing process change for axicabtagene ciloleucel (axi-cel), according to a press release from the biotechnology company Kite, the manufacturer of the therapy.

This manufacturing process change results in a shorter manufacturing time for axi-cel, with Kite’s median turnaround time expected to be reduced from 16 days to 14 days in the United States, the company reported. Median turnaround time is defined as the time from leukapheresis, in which a patient’s T-cells are collected, to product release. Manufacturing prepares each patient’s cells for a customized, one-time therapy infusion.

Axi-cel is a chimeric antigen receptor (CAR) T-cell therapy first approved by the FDA in April 2022 for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapsed within 12 months of first-line treatment. The approval was based on the results of the ZUMA-7 trial, in which axi-cel demonstrated a clinically meaningful and statistically significant improvement in event-free survival compared with the current standard of care.  

Original Source: FDA Approves Shorter Manufacturing Time for Axi-Cel | Blood Cancers Today

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