Incyte announces first data from REACH3 trial showing ruxolitinib improved outcomes in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease
The approval for use in adults and young patients aged years and older, was based on data from the phase 3 APeX-2 trial, which showed that berotralstat could significantly reduce attacks at the 24-week mark, which was sustained through 48 weeks in the study.
Source:
Biospace Inc.
SPS commentary:
Ruxolitinib was approved in US in 2019 for the treatment of steroid-refractory acute graft-versus-host disease in patients aged ≥ 12 years, based on the positive results of the phase 2 REACH1 trial, In the UK, it is currently only licensed for the treatment of myelofibrosis and polycythaemia vera.