meRfi®-GM

This phase III open-label, randomized trial evaluated the efficacy and safety of ruxolitinib at a dose of 10 mg twice daily, as compared with the investigator’s choice of therapy from a list of 10 commonly used options considered best available care (control), in patients 12 years of age or older with moderate or severe glucocorticoid-refractory or -dependent chronic GVHD.

Primary outcome measures:
Overall response (complete or partial response) at week 24

Using ruxolitinib for the treatment of chronic graft-versus-host disease (cGVHD) after the failure of one or two lines of systemic therapy, responses were observed in 64%-70%, with complete response in 3%-8%. The approval of ruxolitinib provides a treatment option for adult and pediatric patients 12 years and older with cGVHD who do not respond to one o…