Summary
Ruxolitinib, the cornerstone treatment for myelofibrosis, polycythemia vera, and graft-versus-host disease, just got easier to take. On May 1, 2026, the FDA approved Jakafi XR™, a once-daily extended-release tablet formulation of the same proven drug. It will be available at pharmacies as early as May 8.
Key Points
- Same medicine, simpler schedule: Jakafi XR (55 mg, once daily) is bioequivalent to standard Jakafi (25 mg, twice daily), delivering the same drug exposure throughout the day
- Who it’s approved for:
- Adults with intermediate- or high-risk myelofibrosis (MF)
- Adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea
- Adults and children 12+ with steroid-refractory acute or chronic graft-versus-host disease (GVHD)
- Safety profile is established: Based on existing Jakafi clinical data, with no new safety concerns introduced with the XR formulation
- Available fast: Pharmacy orders open May 8, 2026
- Patient support: Eligible U.S. patients can access financial assistance and personalized support through IncyteCARES at incytecares.com or 1-855-452-5234 (Mon–Fri, 8 a.m.–8 p.m. ET)
“Patients living with chronic conditions like MPNs and GVHD often struggle with managing complex treatment regimens or have multiple conditions. Since its initial approval in 2011, ruxolitinib has helped transform the treatment landscape for patients with MPNs and GVHD. With the approval of Jakafi XR, appropriate patients now have the choice of a single daily tablet.” — Naveen Pemmaraju, M.D., Professor of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Why It Matters
For MPN (MF, PV) and GVHD patients already managing fatigue, lab monitoring, and often multiple medications, twice-daily dosing is a daily reminder of their disease. The approval of Jakafi XR doesn’t change the science. It removes friction. A once-daily tablet may seem like a small shift, but for patients with pill fatigue or busy schedules, consistency and simplicity directly impact adherence. If you’re currently on twice-daily Jakafi, this is worth a conversation with your healthcare team to see if Jakafi XR is the right fit for you.
For full prescribing information and safety details, visit Jakafi.com.
Sources: Incyte Press Release via Business Wire, May 1, 2026 | Incyte Investor Relations
