FDA approves once-daily Jakafi XR for some myelofibrosis patients
New formulation cleared for adults with intermediate- or high-risk disease
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The U.S. Food and Drug Administration (FDA) has approved a new once-daily formulation of Jakafi (ruxolitinib), known as Jakafi XR, for adults with intermediate- or high-risk myelofibrosis.
Like the original version of Jakafi, which is taken twice daily, Jakafi XR is also FDA-approved to treat certain people with polycythemia vera and acute or chronic graft-versus-host disease (GVHD). Both versions of the medication are sold by Incyte.
“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,” Bill Meury, CEO of Incyte, said in a company press release.
Myelofibrosis refers to a group of myeloproliferative neoplasms (MPNs), blood cancers characterized by the abnormal growth of certain blood cells that leads to fibrosis (scarring) of the bone marrow. The active agent in Jakafi, ruxolitinib, blocks the activity of JAK1 and JAK2, two proteins that drive the abnormal growth of blood cells that cause the disease. In myelofibrosis, the therapy’s dose is determined by a patient’s blood cell counts.
Simplifying life for patients
The original version of Jakafi was approved by the FDA in 2011, based on clinical trial data showing that the therapy was superior to a placebo in easing myelofibrosis symptoms. Those trials also showed that the therapy helped to reduce the size of the spleen, an organ involved in blood cell maintenance that often becomes enlarged in people with the disease.
Approval of the new, once-daily Jakafi XR was based on a clinical study showing that a single 55 mg tablet taken once a day delivers the same amount of active ruxolitinib as a 25 mg immediate-release Jakafi tablet taken twice a day.
“Patients living with chronic conditions like MPNs and GVHD often struggle with managing complex treatment regimens or have multiple conditions,” said Naveen Pemmaraju, MD, a professor at the University of Texas MD Anderson Cancer Center. “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.”
Incyte offers a patient support program called IncyteCARES that offers resources including financial support for eligible patients who have been prescribed Jakafi or Jakafi XR.
