Incyte’s Jakavi (ruxolitinib) Receives EC’s Approval as the First Post-Steroid Treatment for Acute and Chronic Graft-Versus-Host Disease
Shots:
- The EC has approved Jakavi for acute or chronic GVHD who has an inadequate response to corticosteroids or other systemic therapies in patients aged ≥12yrs. Ruxolitinib is marketed as Jakavi by Novartis in the EU & as Jakafi by Incyte in the US
- The approval was based on the P-III (REACH2) & (REACH3) studies of Jakavi which showed superior ORR over BAT. In (REACH2) study, ORR (62% vs 39%) @Day 28, while in (REACH3) study, ORR (50% vs 26%) @24wks. with the best ORR (76% vs 60%) in steroid-refractory/dependent chronic GVHD patients
- Jakafi is a JAK1/2 inhibitor & was approved in the US for PV in adults who have had an inadequate response to or are intolerant of hydroxyurea, intermediate or high-risk MF
Ref: Businesswire | Image: Incyte
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