FDA
Once‑daily Jakafi XR approved to simplify hematologic and transplant care
Image source: Incyte
On May 1, 2026, FDA approved Jakafi XR (ruxolitinib) extended‑release tablets, marking the introduction of a once‑daily formulation of the established JAK1/JAK2 inhibitor. The new extended‑release, film‑coated tablet provides consistent, day‑long ruxolitinib exposure comparable to twice‑daily immediate‑release Jakafi, reducing dosing frequency without changing expected clinical benefit.
Jakafi XR is approved for:
- adults with intermediate‑ or high‑risk myelofibrosis (MF)
- adults with polycythemia vera (PV) who are intolerant of or refractory to hydroxyurea
- adults and pediatric patients aged 12 years and older with steroid‑refractory acute or chronic graft‑versus‑host disease (GVHD) after one or two prior systemic therapies
FDA approval was supported by a clinical study demonstrating bioequivalence between Jakafi XR 55 mg once daily and Jakafi immediate‑release 25 mg twice daily, with comparable steady‑state exposure over 24 hours—suggesting similar efficacy outcomes while easing daily treatment burden.
The safety profile of Jakafi XR is supported by data from adequate and well‑controlled studies of the Jakafi immediate‑release formulation in adults with MF and PV, as well as in adult and pediatric patients with acute and chronic GVHD. In patients with MF and PV, the most frequently reported reactions included thrombocytopenia or anemia, along with bruising, dizziness, headache, and diarrhea. Among patients treated for acute GVHD, common adverse events included low platelet and red or white blood cell counts, infections, and peripheral edema. In chronic GVHD, cytopenias—particularly anemia and thrombocytopenia—and infections, including viral infections, were most commonly observed.
“Patients living with chronic conditions like myeloproliferative neoplasms and GVHD often struggle with managing complex treatment regimens or have multiple conditions,” said Naveen Pemmaraju, MD, of The University of Texas MD Anderson Cancer Center. “With the approval of Jakafi XR, appropriate patients now have the choice of a single daily tablet.”
Jakafi XR is expected to be available for pharmacy orders beginning May 8.
Source: Incyte. (2026, May 1). Press release. Incyte Announces FDA Approval of Jakafi XR (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease