Incyte seeks broader Jakafi label
Incyte is working to expand the indication for Jakafi (ruxolitinib), which is currently approved for patients with intermediate or high-risk myelofibrosis.
The company announced Tuesday that it has filed a request that the FDA allow its roster of applications to include patients with polycythemia vera who have had poor response or cannot tolerate hydroxyurea. Polycythemia vera is an overabundance of red blood cells, white blood cells and platelets and is associated with an increased risk of blood clots.
Incyte is also testing the drug among patients with pancreatic cancer, non-small-cell lung cancer, colorectal cancer and breast cancer.
Jakafi earned $84 million in second-quarter sales, an effort that was backed by Incyte's increased investment in its sales force, part of which was in preparation for the anticipated polycythemia vera indication.