The US Food and Drug Administration (FDA) has approved ruxolitinib (Jakafi XR) extended-release tablets for adults with intermediate or high-risk myelofibrosis and adults with polycythemia vera who did not respond well to hydroxyurea. It also includes patients ages 12 years and older with steroid-refractory acute or chronic graft-versus-host disease.
“Patients living with chronic conditions like MPNs and GVHD often struggle with managing complex treatment regimens or have multiple conditions,” said Naveen Pemmaraju, MD, professor of leukemia 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.”
Approval was based on a clinical study showing that a single 55 mg tablet of Jakafi XR is bioequivalent to two 25 mg doses of the immediate-release form. This new once-daily formulation delivers the active ingredient at comparable levels to the twice-daily immediate-release version, according to the press release by Incyte, the therapy’s manufacturer.
“The approval of Jakafi XR offers appropriate patients and physicians a once-daily option, expanding choice without changing the well-established role of Jakafi in clinical practice,” said Bill Meury, CEO of Incyte.
