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

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

More from Drug Safety

More from Pink Sheet