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Tocilizumab Shortage Prompts US FDA To Loosen CAR-T REMS Requirements

 
• By Brenda Sandburg

CAR-T cell immunotherapies can be administered when only one dose of Roche's Actemra is available on-site for each patient, rather than two doses required under REMS for the immunotherapies. The change is one of the few pandemic-related REMS revisions that has been made public. 

Tocilizumab
US FDA modifies REMS mandating tocilizumab availability for CAR-T cell treatment • Source: Alamy

Struggling to cope with the shortage of Roche Holding AG’s Actemra (tocilizumab) following its authorization for use in hospitalized COVID-19 patients, the US Food and Drug Administration has eased Risk Evaluation and Mitigation Strategy requirements mandating availability of the drug.

Tocilizumab is itself not subject to a REMS, but access to the drug is required under the REMS for chimeric antigen receptor T-cell (CAR-T) immunotherapies

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