New Data for Jakafi® (ruxolitinib) to Be Presented at the 2012 American Society of Hematology Annual
New Data for Jakafi® (ruxolitinib) to Be Presented at the 2012 American Society of Hematology Annual Meeting
Incyte to host a webcast for investors featuring highlights from multiple presentations on Monday, Dec. 10 at 8:45 p.m. EST
WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte Corporation (NAS: INCY) announced today that several analyses from clinical studies of Jakafi® (ruxolitinib) will be presented at the 2012 American Society of Hematology (ASH) Annual Meeting from Dec. 8 to 11 at the Georgia World Congress Center in Atlanta. Jakafi, an oral Janus kinase (JAK) inhibitor, is FDA-approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF).
The following abstracts, which are related to the use of Jakafi in patients with MF, will be oral presentations (dates, times and locations of the presentations are included):
Abstract #176 - Oral Presentation - Sunday, Dec. 9, 4:45 p.m. EST
Talpaz, M, et al. Efficacy, hematologic effects, and dose of ruxolitinib in myelofibrosis patients with low starting platelet counts (50-100 x 109/L): A comparison to patients with normal or high starting platelet counts.
Location: B213-B214, Level 2, Building B
Abstract #177 - Oral Presentation - Sunday, Dec. 9, 5 p.m. EST
Harrison, C, et al. Expand: a Phase 1b, open-label, dose-finding study of ruxolitinib in patients with myelofibrosis and baseline platelet counts between 50 × 109/L and 99 × 109/L.
Location: B213-B214, Level 2, Building B
Abstract #800 - Oral Presentation - Monday, Dec. 10, 6:30 p.m. EST
Verstovsek, S, et al. Long-term outcome of ruxolitinib treatment in patients with myelofibrosis: Durable reductions in spleen volume, improvements in quality of life, and overall survival advantage in COMFORT-I.
Location: B213-B214, Level 2, Building B
Abstract #801 - Oral Presentation - Monday, Dec. 10, 6:45 p.m. EST
Cervantes, F, et al. Long-term safety, efficacy, and survival findings from COMFORT-II, a Phase III study comparing ruxolitinib with best available therapy for the treatment of myelofibrosis.
Location: B213-B214, Level 2, Building B
Abstract #802 - Oral Presentation - Monday, Dec. 10, 7 p.m. EST
Vannucchi, A, et al. Reductions in JAK2 V617F allele burden with ruxolitinib treatment in COMFORT-II, a Phase III study comparing the safety and efficacy of ruxolitinib with best available therapy.
Location: B213-B214, Level 2, Building B
The following abstracts, which are related to the use of Jakafi in patients with MF, will be presented during poster sessions:
Abstract #1727 - Poster Presentation - Saturday, Dec. 8, 5:30-7:30 p.m. EST
Mesa, R, et al. Clinical benefits of ruxolitinib therapy in myelofibrosis patients with varying degrees of splenomegaly and symptoms.
Location: Hall B1-B2, Level 1, Building B
Abstract #1733 - Poster Presentation - Saturday, Dec. 8, 5:30-7:30 p.m. EST
Mesa, R, et al. Improvement in weight and total cholesterol and their association with survival in ruxolitinib-treated patients with myelofibrosis from COMFORT-I.
Location: Hall B1-B2, Level 1, Building B
Abstract #2838 - Poster Presentation - Sunday, Dec. 9, 6-8 p.m. EST
McMullin, M, et al. The use of erythropoietic-stimulating agents with ruxolitinib in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis.
Location: Hall B1-B2, Level 1, Building B
Abstract #2847 - Poster Presentation - Sunday, Dec. 9, 6-8 p.m. EST
Verstovsek, S, et al. Effect of ruxolitinib on the incidence of splenectomy in patients with myelofibrosis: A retrospective analysis of data from ruxolitinib clinical trials.
Location: Hall B1-B2, Level 1, Building B
Abstract #4255 - Poster Presentation - Monday, Dec. 10, 6-8 p.m. EST
Ouagari, K, et al. Cost-effectiveness of ruxolitinib versus best-available therapy for medical treatment of myelofibrosis: Canadian societal perspective.
Location: Hall B1-B2, Level 1, Building B
Other data related to Jakafi to be presented at ASH include:
Abstract #2844 - Poster Presentation - Sunday, Dec. 9, 6-8 p.m. EST
Barosi, G, et al. An individual patient supply program for ruxolitinib for the treatment of patients with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis.
Location: Hall B1-B2, Level 1, Building B
Abstract #804 - Oral Presentation - Monday, Dec. 10, 7:30 p.m. EST
Verstovsek, S, et al. Long-term efficacy and safety results from a Phase II study of ruxolitinib in patients with polycythemia vera.
Location: B213-B214, Level 2, Building B
About the Webcast
Incyte will host an investor meeting to discuss the new Jakafi data being presented at ASH. The presentation will be webcast live at 8:45 p.m. EST on December 10, 2012, and can be accessed at www.incyte.com under Investor Relations, Events and Webcasts. A replay of the event will be available for 60 days.
About Jakafi
Jakafi is a prescription medicine used to treat people with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF.
Important Safety Information
Treatment with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia, which are each dose-related effects, with the most frequent being thrombocytopenia and anemia. A complete blood count must be performed before initiating therapy with Jakafi. Complete blood counts should be monitored as clinically indicated and dosing adjusted as required. The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache
Patients with platelet counts <200 × 109/L at the start of therapy are more likely to develop thrombocytopenia during treatment. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If clinically indicated, platelet transfusions may be administered
Patients developing anemia may require blood transfusions. Dose modifications of Jakafi for patients developing anemia may also be considered
Neutropenia (ANC <0.5 × 109/L) was generally reversible and was managed by temporarily withholding Jakafi
Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections. Active serious infections should have resolved before starting Jakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection (including herpes zoster) and initiate appropriate treatment promptly
A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or in patients with renal or hepatic impairment [see Dosage and Administration]. Patients should be closely monitored and the dose titrated based on safety and efficacy
There are no adequate and well-controlled studies of Jakafi in pregnant women. Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus
Women taking Jakafi should not breast-feed. Discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
For Full Prescribing Information for Jakafi, visit www.Jakafi.com.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs for oncology and inflammation. For additional information on Incyte, please visit the Company's website at www.incyte.com.
Incyte Corporation
Pamela M. Murphy
Vice President, Investor Relations & Corporate Communications
302-498-6944
KEYWORDS: United States North America Delaware Georgia
INDUSTRY KEYWORDS:
The article New Data for Jakafi® (ruxolitinib) to Be Presented at the 2012 American Society of Hematology Annual Meeting originally appeared on Fool.com.
Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright © 1995 - 2012 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.
