CHMP recommends approval of Jakavi for acute graft-versus-host disease or chronic graft-versus-host disease.- Incyte
Incyte announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute graft-versus-host disease or chronic graft-versus-host disease (GVHD) and who have inadequate response to corticosteroids or other systemic therapies.
If approved, ruxolitinib will be the first JAK1/2 inhibitor available for patients with GVHD in Europe.
The CHMP positive opinion was based on data from the Phase III REACH2 and REACH3 clinical studies, in which ruxolitinib demonstrated superiority versus best available therapy (BAT) in patients with steroid-refractory and steroid-dependent acute and chronic GVHD, respectively. Results from the REACH2 trial showed an overall response rate (ORR) at Day 28 was superior in the ruxolitinib arm at 62.3% vs. 39.4% in the BAT arm (odds ratio [OR], 2.64; p<0.001) in patients with steroid refractory dependent acute gvhd; and in those patients who maintained response at day 56, the orr in the jakavi arm was 40% vs. 22% in the bat arm (p><0.001).></0.001).></0.001)>
In REACH3, treatment with ruxolitinib led to significant improvements in ORR compared to BAT (49.7% vs. 25.6%; OR, 2.99; P<0.0001) in patients with steroid refractory dependent chronic gvhd at week 24, the primary endpoint of the study, regardless of the individual organs involved at baseline. also, best overall response (bor) rate at any time up to week 24 was achieved in 76.4% of patients in the ruxolitinib arm compared to 60.4% in the bat arm (or, 2.17; 95% ci, 1.34-3.52). results from the two studies were published in the april 22, 2020 (reach2), and july 15, 2021 (reach3) issues of the new england journal of medicine ( previously cited).></0.0001)>
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