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Incyte Will File Jakafi For Acute GVHD In US Based On Phase II Success

 
• By Joseph Haas

The JAK1/2 inhibitor may add an indication for acute graft-versus-host disease, though based on a single, open-label Phase II trial that showed a 55% response rate in a high-mortality indication.

Testing the drug on the basis of stem cell

Incyte Corp. is drawing closer to a third US indication for its JAK1/2 inhibitor Jakafi, reporting successful top-line data from the Phase II REACH1 study in steroid-refractory, acute graft-versus-host disease (GVHD). The company intends to file a supplemental new drug application (sNDA) for that application during the third quarter of 2018.

Jakafi (ruxolitinib) is also being testing for GVHD in the Phase III REACH2 and REACH3 studies, in acute steroid-refractory GVHD and chronic steroid-refractory GVHD, respectively, which are expected to report...

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