Incyte recently announced that the US Food and Drug Administration (FDA) has approved Jakafi XR (ruxolitinib) extended-release tablets for the treatment of 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; as well as adults and children aged 12 years and older with steroid-refractory acute Graft-Versus-Host Disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy.

Bill Meury, Chief Executive Officer (CEO), Incyte, said, “The approval of Jakafi XR reinforces Incyte’s leadership in hematology and our focus on meeting the evolving needs of patients with myeloproliferative neoplasms (MPNs) and GVHD. Jakafi XR offers appropriate patients and physicians a once-daily option, expanding choice without changing the well-established role of Jakafi in clinical practice.”

FDA approval was based on a clinical study which demonstrated that a single 55 mg Jakafi XR tablet taken once-daily (QD) is bioequivalent to a single 25 mg Jakafi tablet, the Immediate-Release (IR) dosage form, taken twice-daily (BID). This means that, based on key measures of steady-state drug exposure, it delivers the same active ingredient at comparable levels throughout the day, indicating the potential for similar clinical benefit.

The safety of Jakafi XR has been established from adequate and well-controlled studies of Jakafi in adult patients with myelofibrosis, PV, and adult and pediatric patients with acute and chronic graft-versus-host-disease.

The most common adverse reactions associated with Jakafi in these studies vary by condition. In patients with myelofibrosis (MF) and PV, commonly reported effects include low platelet or Red Blood Cell (RBC) counts, bruising, dizziness, headache, and diarrhea. For patients with acute GVHD, adverse reactions include low platelet counts, reduced red or White Blood Cell (WBC) counts, infections, and swelling. In those with chronic GVHD, the most frequent side effects are low RBC or platelet counts and infections, including viral infections.

Naveen Pemmaraju, M.D., Professor of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, said, “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.”

Researchers at UT MD Anderson have led several clinical trials in the development of ruxolitinib.