Definitely on SYC's Ominicar 'dance card' :-With the approval...

Definitely on SYC's Ominicar 'dance card' :-

With the approval will come a black-box warning label for both cytokine release syndrome, a potentially fatal overreaction of the immune system, as well as neurologic toxicities.
Those warnings are severe enough that the FDA has instituted a Risk Evaluation and Mitigation Strategy that will require healthcare facilities and physicians administering the therapy to be specially certified to identify and treat CRS and neuro toxicities.
Those warnings and administration restrictions are aren’t unique toliso-cel, however. Yescarta and Kymriah, for instance, sport the same black box warnings, and the unmet clinical need will likely drive uptake in what is an extremely difficult-to-treat patient population.