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FDA just granted Breakthrough Therapy Designation for the first treatment for acute graft-versus-host disease (GVHD): ruxolitinib (Jakafi, Incyte Corp.).
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GVHD is a condition that might occur after an allogeneic transplant (the transfer of genetically dissimilar stem cells or tissue). In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and attack the body.
Jakafi, which is marketed by Novartis as Jakavi outside the United States, is already approved in the US for people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
“Receiving breakthrough therapy designation from the FDA recognizes the severe nature of acute GVHD, the clear unmet medical need of these patients, and the potential, based on clinical evidence to date, for ruxolitinib to address the urgent needs of patients with this life-threatening disease,” said Steven Stein, MD, Incyte’s chief medical officer. “We are committed to working closely with the FDA in an effort to bring ruxolitinib to patients with GVHD as soon as possible.”
There are 2 forms of GVHD; acute and chronic. GVHD is a significant cause of morbidity and mortality in transplant recipients. The skin, gastrointestinal (digestive) tract, and liver are the most commonly affected organs in patients with GVHD.
The most common side effects of Jakafi include low platelet count, low red blood cell counts, bruising, dizziness and headache. Patients taking Jakafi also have a higher risk of contracting certain types of non-melanoma skin cancers and developing inflections, as well as increased cholesterol levels.