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# FDA OKs ‘Major’ Yescarta, Tecartus REMS Changes
- URL: https://www.fdaweb.com/fda-oks-major-yescarta-tecartus-rems-changes/
- Published: 2024-06-20T12:00:00.000Z
- Updated: 2026-09-14T14:33:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157210

FDA has approved a major modification to the Risk Evaluation and Mitigation Strategy (REMS) for Kite Pharma’s lymphoma drugs Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). An agency [notice](https://www.fda.gov/media/179362/download?attachment&ref=fdaweb.com) says FDA has determined that the REMS must be modified to minimize the burden on the healthcare delivery system of complying with it. These are the required modifications:

- modification to REMS goals to remove the goal for “ensuring those who prescribe, dispense, or administer Yescarta and/or Tecartus are aware of how to manage the risks of CRS (cytokine release system) and neurological toxicities”;
- removal of the requirement for specified educational and training materials; and
- removal of the requirement to report any serious adverse events suggestive of CRS or neurological toxicities to the REMS.