The sNDA submission for ruxolitinib to treat steroid-refractory chronic graft-versus-host disease in adult and pediatric patients 12 years and older was based on the phase 3 REACH3 study, which is assessing the safety and efficacy of ruxolitinib compared with best available therapy.
A promising approach to treating newly diagnosed acute graft-versus-host disease emerges, based on data regarding the use of the humanized IgG1 monoclonal antibody itolizumab.
A supplemental new drug application submission was primarily based on safety and efficacy data from the global phase 3 ASPEN trial of zanubrutinib compared with ibrutinib for the treatment of Waldenström macroglobulinemia.