Novartis's Jakavi ® shows positive Phase III results in Polycythemia Vera
Novartis announced that Jakavi ® (ruxolitinib) showed positive reponse in compare to present therpies for Polycythemia Vera, a rare and incurable blood cancer with increase number of erythrocytes production. In phase III trial, Jakavi ® succeed to maintain hematocrit control, erythrocytes volume, without the need of phlebotomy and reducing spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea.
"We are encouraged by these pivotal Phase III trial results, which show the potential of ruxolitinib to help patients with polycythemia vera," said Alessandro Riva, President, Novartis Oncology ad interim and Global Head, Oncology Development and Medical Affairs. "We plan to submit these data to worldwide regulatory agencies this year, as we seek to bring ruxolitinib to patients with polycythemia vera who are no longer responding to or are intolerant of prior therapy."
Global, randomized, open-label study conducted at 109 sites. The 222 patients with polycythemia vera were included in trial who were resistant to or intolerant of hydroxyurea. The dose of Ruxolitinibis was adjusted as needed throughout the study.
Ruxolitinibis is also approved for myelofibrosis, a debilitating and life-threatening blood cancer in more than 55 countries.