Incyte Corporation (Nasdaq:INCY) today announced that further analyses from the global, pivotal Phase III clinical program of Jakafi (ruxolitinib or INC424) are being presented at the 2011 American Society of Hematology (ASH) Annual Meeting. The presentations include:
Verstovsek S, et al. Consistent benefit of ruxolitinib over placebo in spleen volume reduction and symptom improvement across subgroups and overall survival advantage: results from COMFORT-I. Abstract 278
Harrison C, et al. Ruxolitinib provides reductions in splenomegaly across subgroups: an analysis of spleen response in the COMFORT-II study. Abstract 279
Mesa R, et al. Associations between improvements in myelofibrosis (MF) symptoms and quality of life measures with splenomegaly reduction in COMFORT-I: a randomized, double-blind, phase III trial of the JAK1 and JAK2 inhibitor ruxolitinib versus placebo in patients with MF. Abstract 3842
Harrison C, et al. Health-related quality of life and symptoms in myelofibrosis patients treated with ruxolitinib versus best available therapy. Abstract 795
Jakafi was recently approved by the US Food and Drug Administration (FDA) for the treatment of intermediate or high-risk myelofibrosis, a potentially life-threatening blood cancer characterized by bone marrow failure, enlarged spleen (splenomegaly) and debilitating symptoms that can severely impact quality of life. Jakafi, an oral JAK1 and JAK 2 inhibitor, is the first and only product to be approved by the FDA for this disease. Jakafi is the first in a new class of drugs, known as JAK-inhibitors, to be approved for any indication.