Incyte Corp. (INCY) Wednesday said the FDA granted marketing approval for Jakafi to treat intermediate or high-risk myelofibrosis, a debilitating, progressive and potentially life-threatening blood cancer. Jakafi is an oral drug, belonging to a new class of drugs, known as JAK inhibitors.
Myelofibrosis or MF belongs to a group of diseases referred to as myeloproliferative neoplasms or MPNs. The FDA approval for Jakafi or ruxolitinib is for the treatment of patients with intermediate or high-risk myelofibrosis, including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. Patients with intermediate and high-risk MF represent 80 to 90 percent of MF patients.
Myelofibrosis, which affects about 3,500 people annually in the United States, is characterized by significant anemia, an enlarged spleen, intense itching, weight loss and bone pain.
The existing treatment options like androgen therapy, chemotherapy, radiation therapy, surgical removal of spleen, blood transfusions and medications like thalidomide plus steroids are capable of only managing the symptoms of myelofibrosis but not effective in curing the disease. Stem cell transplants are considered the only cure for myelofibrosis.
Jakafi is an inhibitor of Janus kinases enzymes - JAK1 and JAK2, that mediate signaling of several important drivers of myeloproliferative neoplasms like myelofibrosis, other hematological malignancies and inflammatory diseases.
The NDA of Ruxolitinib was based on the results of two phase III - COMFORT-I and COMFORT-II trials conducted as part of the Incyte-Novartis worldwide collaboration and license agreement. The COMFORT-I trial met its primary endpoint of reduction in spleen volume, 41.9 percent of patients treated with Jakafi experienced a 35 percent or greater reduction in spleen volume at 24 weeks. For placebo, the reduction was experienced by 0.7 percent of patients.
COMFORT-I also demonstrated improvements in symptoms as measured by the modified Myelofibrosis Symptom Assessment Form or MFSAF v.2.0 electronic diary and the MFSAF Total Symptom Score (TSS) comprised of six specific symptoms.
The COMFORT-II trial was conducted by Novartis, Incyte's collaboration partner outside of the U.S. It compared Jakafi to best available therapy and the trial showed that 28.5 percent of patients treated with Jakafi experienced a 35 percent or greater reduction in spleen volume at 48 weeks, compared with 0 percent of patients in the best available therapy arm.
As per an agreement signed with Incyte in 2009, Novartis holds exclusive rights to the development and potential commercialization of ruxolitinib in all hematology-oncology indications outside of the United States.
Incyte has established IncyteCARES, a comprehensive program that provides reimbursement support and educational resources for patients. Jakafi will be available in the United States next week through a number of specialty pharmacies.
INCY is currently trading at $13.61, up $1.01 or 8.02%, on the Nasdaq. over the past year, the stock traded in a range of $12.32 - $21.15.
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