Incyte Announces Acceptance and Priority Review of sNDA for Jakafi (ruxolitinib) as a Treatment for Patients with Chronic Graft-Versus-Host Disease - Seite 2

The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the review period to six months compared to 10 months for Standard Review. The Prescription Drug User Fee Act (PDUFA) target action date for Jakafi in steroid-refractory chronic GVHD is June 22, 2021.

The sNDA is also being reviewed as part of the Project Orbis program, an initiative of the U.S. FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among international regulatory agencies. Participating countries for this application include Canada, Australia, Switzerland, Brazil and the United Kingdom.

In 2019, Jakafi was approved by the U.S. Food and Drug Administration for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older².

About REACH3

REACH3 (NCT03112603), a randomized, open-label, multicenter Phase 3 study sponsored by Novartis and conducted in collaboration with and co-funded by Incyte, is evaluating the safety and efficacy of ruxolitinib compared with best available therapy in patients with steroid-refractory chronic GVHD.

The primary endpoint is overall response rate (ORR) at Week 24 (i.e., Cycle 7, Day 1), defined as the percentage of participants demonstrating a complete or partial response. Key secondary endpoints include failure-free survival (FFS) and change in the modified Lee Symptom Scale (mLSS) score at Week 24. Other secondary endpoints include best overall response (BOR), duration of response (DoR), overall survival (OS), and safety. For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03112603.

About REACH

The REACH clinical trial program evaluating ruxolitinib in patients with steroid-refractory GVHD includes the randomized pivotal Phase 3 REACH2 and REACH3 trials, conducted in collaboration with Novartis.

The REACH program was initiated with the Incyte-sponsored REACH1 trial, a prospective, open-label, single-cohort, multicenter, pivotal Phase 2 trial (NCT02953678) evaluating Jakafi in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD. For more information about the study, including trial results, please visit https://clinicaltrials.gov/show/NCT02953678.

About Jakafi (ruxolitinib)

Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults, and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.