Exciting news from the CEO of Incyte recently captured the attention of the pharmaceutical industry, specifically the significant success of their oncology drug Ruxolitinib. A Phase III comprehensive study of Ruxolitinib in patients with polycythemia vera indicated extremely positive results, leading Incyte to tout these statistics and announce a plan for a supplemental new drug application later this calendar year. Known as the brand name Jakafi, Ruxolitinib is currently FDA approved for use in treating primary myelofibrosis, or MF, as well as post–essential thrombocythemia myelofibrosis and post–polycythemia vera myelofibrosis. A potential blockbuster status for Ruxolitinib is eyed by executives from both Incyte and Novartis, which would be epic for this patient populous. As a rare blood cancer without sizable research and development, polycythemia vera is marked by the excess of red blood cells which thicken the blood and often lead to life threatening complications such as a heart attack or stroke. Polycythemia vera affects roughly 50 out of every 100,000 Americans, with many people suffering from this disease worldwide as well. While scientists are unclear about what specifically initiates polycythemia vera, researchers are aware that patients with the JAK2 and TET2 gene mutations are predisposed to this disease.
The aforementioned successful Phase III study involved 222 patients with polycythemia vera, also known as PV. These patients had previously received best in care treatment with hydroxyurea, which did not prove efficacious. The primary endpoint of the study was to aid patients by not only normalizing their red blood cell counts, but also by reducing their spleen size by at least 35 percent. Study statistics overwhelmingly showed that patients responded to these primary endpoints, as well as additional secondary endpoints of a durable response rate and complete hematological remission. Coined RESPONSE, this Phase III trial involved testing at 109 U.S. sites, where participants were randomized to receive either 10 milligrams of Ruxolitinib two times a day or best available therapy. Some dose adjustments were made throughout the duration of the trial, based on individual patient’s needs. Dizziness and headache were most commonly reported side effects, and the vast majority of patients found Ruxolitinib to be tolerable and safe.
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