Industry News

FDA Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs Within Bristol Myers Squibb’s Cell Therapy Labels

On June 26, the FDA approved label updates for both of Bristol Myers Squibb's CAR T-cell therapies: lisocabtagene maraleucel (liso-cel) for the treatment of large B cell lymphoma and other lymphomas and idecabtagene vicleucel (ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the risk evaluation and mitigation strategy programs that had been in place since each product was initially approved.

For more information, read the Bristol Myers Squibb press release.

Posted on 7/7/2025


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