Incyte’s Jakafi (ruxolitinib) Receives the US FDA’s Approval for the Treatment of Chronic Graft-Versus-Host Disease

September 23, 2021 Auto Bot approval, FDA, Incyte, regulatory 0

Shots:

  • The approval is based on the P-III REACH3 study evaluates the safety & efficacy of Jakafi vs BAT in patients ≥12yrs. with steroid-refractory chronic GVHD after the failure of 1 or 2 lines of systemic therapy
  • The results showed that the patients treated with Jakafi led to significantly improved outcomes across a range of efficacy measures, ORR (49.7% vs 25.6%) @24wks. Additionally, ORR (70% vs 57%) through Cycle 7 Day 1. The results were published in the NEJM
  • Jakafi is a JAK1/JAK2 inhibitor & marks 4th FDA-approved indication. Patients treated with Jakafi have access to the IncyteCARES program that offers patient support, including financial assistance, education & resources

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