Incyte drug gains expanded indication for bone marrow disease
FDA has approved Jakafi (ruxolitinib) for use in treating patients with polycythemia vera, a chronic type of bone marrow disease.
In the new indication, Jakafi is intended to treat polycythemia vera patients who have an inadequate response to or cannot tolerate hydroxyurea, another medicine often prescribed to reduce the number of red blood cells and platelets in the blood.
Jakafi was approved in 2011 for treating another bone marrow disorder, intermediate or high-risk myelofibrosis. Incyte has also been testing the drug for pancreatic cancer, non-small-cell lung cancer, colorectal cancer and breast cancer.
The trial used to evaluate Jakafi confirmed clinically meaningful reductions in spleen size and the need for phlebotomies to control the disease, which occurs when too many red blood cells are made in the bone marrow.The drug was evaluated under orphan product designation and expedited priority review after demonstrating the potential to be a significant improvement over available therapy.