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# Incyte sNDA for Graft-vs-host Disease OK’d
- URL: https://www.fdaweb.com/incyte-snda-for-graft-vs-host-disease-okd/
- Published: 2021-09-22T12:00:00.000Z
- Updated: 2026-09-14T17:15:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150201

FDA has approved an Incyte supplemental NDA for Jakafi (ruxolitinib) for treating chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Approval is based on data from the Phase 3 REACH3 study of Jakafi in comparison to best available therapy (BAT) for treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation, the company says. The primary endpoint of overall response rate was 49.7% for Jakafi compared to 25.6% for BAT. The most common hematologic adverse reactions were anemia and thrombocytopenia, and the most common nonhematologic adverse reactions were infections (pathogen not specified) and viral infection, it says.

Jakafi is a JAK1/JAK2 inhibitor that was previously approved for treating polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. It is also approved for intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults, and for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.