Ph III study for Jakavi meets endpoint in patients with polycythemia vera

7 March 2014

Swiss pharma major Novartis (NOVN: VX) today announced positive results from a pivotal Phase III trial of Jakavi (ruxolitinib) compared to best available therapy in the treatment of a rare blood cancer.

The study met its primary endpoint of maintaining hematocrit control (red blood cell volume) without the need for phlebotomy (a procedure to remove blood from the body to reduce the concentration of red blood cells) and reducing spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea.

The safety profile of ruxolitinib was generally consistent with previous studies based on initial review of the data. Data from the study (RESPONSE) will be presented at an upcoming medical congress and submitted to worldwide regulatory authorities this year.

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