Novartis (NVS) announced positive data from a phase III trial, RESPONSE, on blood cancer drug Jakavi.
Novartis is seeking a label expansion for Jakavi for the indication of rare blood cancer, polycythemia vera.
The results from the global, randomized, open-label study, RESPONSE (n=222), showed that Jakavi 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), as compared to the best available therapy.
Jakavi was also able to reduce spleen size in patients suffering from polycythemia vera who were resistant to or intolerant of hydroxyurea.
In addition, the safety profile of Jakavi was generally consistent with the previous studies as observed from the initial review of the data.
Based on encouraging data from the trial, Novartis plans to submit these data to worldwide regulatory agencies later in 2014.
We remind investors that Jakavi is already approved in the EU and the U.S. for the treatment of patients with myelofibrosis.
We note that Incyte Corp. (INCY) markets Jakavi under the trade name ‘Jakafi” in the U.S.
Jakavi enjoys orphan drug status for the indication of myelofibrosis, both in the U.S. and EU. Jakavi generated sales of $163 million in 2013, up from $30 million in 2012. We are encouraged by Novartis’ efforts to expand Jakavi’s label which should boost sales.