Incycte Corporation's recent clinical trial of Jakafi (ruxolitinib) found that the drug considerably reduced spleen volume while improving hematocrit control in patients with uncontrolled polycythemia vera (PV), a rare type of blood cancer.
Results of the study were recently published in The New England Journal of Medicine.
“The publication of the data from our pivotal RESPONSE Phase III study demonstrates the importance of Jakafi as the first FDA-approved treatment for patients with uncontrolled polycythemia vera,” Rich Levy, Incyte’s executive vice president, chief drug development and medical officer, said.
Currently, there are approximately 100,00 patients with PV in the United States.
PV is categorized by an overabundance of red blood cells, which may lead to blood thickening and a higher risk for blood clots, as well as high white blood cell and platelet counts.
Traditional PV treatment consists of removing blood from the body and aspirin. When regular treatment ceases to control PV, chemotherapy is used. Approximately 1 out of 4 patients have adverse side effects to commonly used chemotherapy, however, and are considered to have uncontrolled PV.
“A key challenge in treating patients with PV is the development of resistance or intolerance to currently available therapies such as hydroxyurea, which leaves us with no effective treatment options to manage the disease,” Alessandro M. Vannucchi, the lead study author, said. “This study indicates that ruxolitinib may represent an important advance for patients with uncontrolled PV.”