FDA Approves Extended-Release Ruxolitinib Across Hematologic Indications

Clinical Summary: 

• The FDA has approved extended-release ruxolitinib for patients with myelofibrosis, polycythemia vera, and graft-versus-host disease, based on pharmacokinetic bioequivalence to the immediate-release formulation.
• Extended-release ruxolitinib provides comparable systemic exposure to twice-daily ruxolitinib, supporting similar efficacy and safety established in prior clinical studies.
• The extended-release formulation introduces a more convenient once-daily dosing option, which may improve adherence while maintaining the established therapeutic role of ruxolitinib.

On May 1, 2026, the US Food and Drug Administration (FDA) approved extended-release ruxolitinib (Jakafi XR; Incyte) for adult patients with intermediate- or high-risk myelofibrosis, adult patients with polycthemia vera who have inadequate response or are intolerant to hydroxyurea, and adult and pediatric patients (≥12 years) with steroid-refractory acute or chronic graft-versus-host disease (GVHD) after systemic therapy failure. 

This approval was based on clinical efficacy and safety data extrapolated from prior adequate and well-controlled studies of immediate-release ruxolitinib across approved indications. Bioequivalence data demonstrated that 55 mg of once daily extended-release ruxolitinib was bioequivalent to 25 mg of twice daily immediate-release ruxolitinib. Steady-state pharmacokinetic parameters showed that the extended-release formulation provided consistent, day-long drug exposure comparable to the twice daily regimen.

The safety profile of extended-release ruxolitinib is consistent with that of immediate-release ruxolitinib. Common adverse reactions include low platelet count, low red or white blood cell count, bruising, dizziness, headache, diarrhea, infections, and swelling, with risks varying by indication. 

“Since its initial approval in 2011, ruxolitinib has helped transform the treatment landscape for patients with [myeloproliferative neoplasms] and GVHD,” stated Naveen Pemmaraju, MD, MD Anderson Cancer Center, Houston, Texas. “With the approval of Jakafi XR, appropriate patients now have the choice of a single daily tablet.” 

Source: 

Incyte. Incyte announces FDA approval of Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of myelofibrosis, polycythemia vera and graft-versus-host disease. Accessed on May 4, 2026. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-fda-approval-jakafi-xrtm-ruxolitinib-extended