ROACTEMRA (tocilizumab), immunosuppressive agent
Reason for request
High clinical benefit in the treatment of severe or life-threatening cytokine release syndrome induced by treatment with chimeric antigen receptor T lymphocytes (CAR T), but no demonstrated clinical advantage inmanagement
ROACTEMRA has been granted a marketing authorisation for the treatment of severe or life-threatening cytokine release syndrome (CRS) induced by chimeric antigen receptor T lymphocyte treatments in adults and children over the age of 2 years.
In light of the very limited retrospective data and of the many uncertainties concerning the estimation of the fraction of responders, ROACTEMRA failed to demonstrate an impact on short-term morbidity and mortality and its contribution cannot be determined.
Its availability allows severe or life-threatening CRS to be treated, particularly in the event of initiation of YESCARTA or KYMRIAH treatment.
Clinical Added Value
|no clinical added value||