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Switzerland : Novartis announces study in NEJM showing Jakavi was superior to standard therapy in rare blood cancer polycythemia vera.

Novartis today announced The New England Journal of Medicine (NEJM) published results from the pivotal Phase III clinical trial demonstrating Jakavi (ruxolitinib) significantly improved hematocrit control without the need for phlebotomy (a procedure to remove blood from the body to reduce the concentration of red blood cells) and reduced spleen size in patients with polycythemia vera (PV) who had an inadequate response to or unacceptable side effects from hydroxyurea as defined according to the modified European LeukemiaNet (ELN) criteria. In PV, hematocrit control and spleen size reduction are key measures of a patient's response to therapy.

PV is a chronic, incurable blood cancer associated with an overproduction of blood cells that can cause serious cardiovascular complications, such as stroke and heart attack. Approximately 25% of patients with PV develop resistance to or intolerance of hydroxyurea and are considered to have uncontrolled disease, which is typically defined as hematocrit levels greater than 45%, elevated white blood cell count and/or platelet count, and may be accompanied by debilitating symptoms and/or enlarged spleen. Elevated white blood cell count and hematocrit are also associated with an increased risk of blood clots.

"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 very limited alternative treatment options to effectively manage the disease," said Dr. Alessandro M. Vannucchi, Azienda Ospedaliera Universitaria Careggi, University of Florence, Italy and lead study author. "This study indicates that ruxolitinib may represent an important advance for this population of patients with PV, a disease that can lead to serious complications and difficult daily symptoms."

At week 32 of the study, 77% of patients randomized to ruxolitinib achieved one or both components of the composite endpoint of hematocrit control (volume percentage of red blood cells in whole blood) without use of phlebotomy or spleen size reduction in comparison with 20% of patients randomized to standard therapy. A significantly greater proportion of patients achieved the composite primary endpoint when treated with ruxolitinib compared to standard therapy (21% compared to 1%, respectively; p

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Publication:Mena Report
Date:Jan 29, 2015
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