Incyte wins U.S. Food and Drug Administration approval for Jakafi XR, a once-daily formulation for myelofibrosis, polycythemia vera, and graft-versus-host disease.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Incyte has received approval from the U.S. Food and Drug Administration (FDA) for Jakafi XR™ (ruxolitinib) extended‑release tablets, a once‑daily oral formulation of ruxolitinib, for use in adults with intermediate‑ or high‑risk myelofibrosis (MF), adults with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea, and adults and pediatric patients aged 12 years and older with steroid‑refractory acute or chronic graft‑versus‑host disease (GVHD) after failure of one or two lines of prior systemic therapy.
The approval is supported by a clinical study showing that a 55 mg once‑daily Jakafi XR tablet is bioequivalent to the immediate‑release (IR) formulation 25 mg twice daily, with comparable steady‑state drug exposure and similar systemic availability, indicating an expected clinical benefit equivalent to the twice‑daily Jakafi regimen.
In a company statement, Bill Meury, Chief Executive Officer of Incyte, noted that the approval expands treatment options by offering a once‑daily alternative while maintaining the established clinical role of ruxolitinib in myeloproliferative neoplasms and graft‑versus‑host disease.
Naveen Pemmaraju of The University of Texas MD Anderson Cancer Center highlighted that ruxolitinib has transformed treatment for myeloproliferative neoplasms and GVHD, and that the extended‑release formulation may help simplify long‑term therapy and improve adherence through less frequent dosing.
The safety profile of Jakafi XR is consistent with prior studies of ruxolitinib. Common adverse reactions include thrombocytopenia, anemia, bruising, dizziness, headache, and diarrhea in patients with myelofibrosis or polycythemia vera; cytopenias, infections, and edema in patients with acute GVHD; and anemia, thrombocytopenia, and infections including viral infections in patients with chronic GVHD.
Ruxolitinib is a selective JAK1/JAK2 inhibitor that targets dysregulated JAK‑STAT signaling pathways in hematologic malignancies and inflammatory conditions.
Myelofibrosis and polycythemia vera are rare chronic myeloproliferative neoplasms characterized by abnormal clonal proliferation of hematopoietic stem cells, leading to aberrant blood cell production, splenomegaly, and risk of complications such as thrombosis, bleeding, and progression to leukemia.
Graft‑versus‑host disease is an immune‑mediated complication following allogeneic hematopoietic stem cell transplantation, in which donor‑derived T cells attack host tissues, potentially affecting the skin, gastrointestinal tract, liver, and other organs and leading to significant morbidity and reduced quality of life.
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About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.