GvHD is a common and potentially life-threatening complication, occurring in approximately half of allogeneic stem cell transplants.
On May 5, 2022, Novartis announced that the European Commission (EC) had approved Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GvHD who have had an inadequate response to corticosteroids or other systemic therapies.
Notably, Jakavi is the first JAK1/2 inhibitor in Europe for the treatment of steroid-refractory graft-versus-host disease (GvHD).
The approval is based on the Phase III REACH2 and REACH3 trials, in which Jakavi demonstrated superior overall response rate (ORR) compared to best available therapy (BAT). At day 28, REACH2 showed an ORR of 62% for Jakavi, compared to 39% for BAT; and REACH3 demonstrated a significantly improved ORR at week 24 in steroid-refractory/dependent chronic GvHD patients (50% vs. 26%), with a higher optimal ORR compared to BAT (76% vs. 60%).
“Today, 30–60% of GvHD patients do not respond to first-line steroid therapy, highlighting the need for new approaches to ensure long-term treatment goals are achieved,” said Dr. Robert Zeiser of the Department of Hematology, Oncology and Stem Cell Transplantation at the University Hospital of Freiburg, Germany. “The approval of Jakavi provides healthcare providers and steroid-dependent or steroid-refractory GvHD patients with a new approach to managing this debilitating and life-threatening disease.”
To date, there has been a lack of established standards of care for both types of patients who do not respond well to first-line steroid therapy. Currently, there are no other approved therapies for GvHD following steroid failure.
