Hematology | Topics

FDA Grants Priority Review to sNDA for Ruxolitinib to Treat Steroid-Refractory cGVHD
February 23, 2021

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.

Newly Diagnosed Acute GVHD Shows Benefit With Itolizumab Use
February 18, 2021

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.

FDA Accepts sNDA for Zanubrutinib for Treatment of Waldenström Macroglobulinemia
February 17, 2021

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.