Press Release : Novartis announces first data from -2-

include urinary tract infections, herpes zoster, weight gain, 
constipation and hypertension. 
 
   Please see full Prescribing Information available at 
http://www.jakavi.com www.jakavi.com. 
 
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   i. Descriptive P value given for ORR at the primary analysis as the 
efficacy boundary was crossed at the interim analysis (ORR, P = 0.0003). 
 
   References 
 
 
   1. Zeiser R, M.D., et al., Ruxolitinib vs Best Available Therapy in Patients 
      With Steroid-Refractory/Steroid-Dependent Chronic Graft-vs-Host Disease: 
      Primary Findings From the Phase 3, Randomized REACH3 Study. Oral 
      presentation at: ASH Annual Meeting; Dec. 4, 2020. 
 
   2. Ferrara JL., et al. Graft-versus-host disease. Lancet. 
      2009;373(9674):1550-1561. 
 
   3. Jaglowski SM, et al. Graft-versus-Host Disease: Why Haven't We Made More 
      Progress? Curr Opin Hematol. 2014;21(2):141-147 
 
   4. Zeiser R, M.D., et al. Ruxolitinib for Glucocorticoid-Refractory Acute 
      Graft-versus-Host Disease. New England Journal of Medicine. 
      2020;382:1800-1810 
 
   5. Jagasia MH, et al. National Institutes of Health Consensus Development 
      Project on Criteria for Clinical Trials in Chronic Graft-versus-Host 
      Disease: I. The 2014 Diagnosis and Staging Working Group report. Biol 
      Blood Marrow Transplant. 2015. 
 
   6. Jakavi(R) (ruxolitinib) tablets: EU Summary of Product Characteristics. 
      Novartis; May 2020. 
 
   7. "A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients with 
      Steroid-Refractory Chronic Graft vs. Host Disease (GvHD) After Bone 
      Marrow Transplantation (REACH3)." ClinicalTrials.gov, 2017, 
      clinicaltrials.gov/ct2/show/NCT03112603. 
 
 
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(END) Dow Jones Newswires

December 04, 2020 12:30 ET (17:30 GMT)