CHMP recommends Jakavi (Incyte/Novartis)for Myelofibrosis

The CHMP of the European Medicines Agency adopted a positive opinion for Jakavi (INC424, ruxolitinib) from Incyte/Novartis for the treatment of disease-related splenomegaly or symptoms in adult patients with primary Myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Globally, there are few available treatments for myelofibrosis, an uncommon, life-threatening blood cancer characterized by multiple severe complications such as bone marrow failure, enlarged spleen (splenomegaly) and shortened survival.The CHMP opinion was based on positive findings from the COMFORT program, which represents the largest myelofibrosis clinical development program to date. Jakavi directly targets the underlying mechanism of disease, significantly reducing splenomegaly and improving symptoms regardless of JAK mutational status, disease subtype or any prior treatment, including hydroxyurea. In the COMFORT-I trial, 41.9% of Jakavi treated patients achieved at least a 35% reduction in spleen volume at 24 weeks from baseline compared to 0.7% of patients in the placebo group (p<0.001). an early analysis of comfort-i shows jakavi treatment resulted in an overall survival benefit as compared to placebo hazard ratio="0.50" 95 confidence interval: 0.25 0.98. jakavi is known as jakafi in the usa.>