FDA Approves Incyte's Jakafi(TM) (ruxolitinib) for Patients with Myelofibrosis
- First and Only FDA-Approved Treatment For Potentially Life-Threatening Blood Cancer
- Product Available Next Week; Incyte Establishes Comprehensive Patient Assistance Program
- Conference Call Scheduled, Today at
Jakafi(TM) (ruxolitinib) is the first and only product to be approved by the
“The availability of Jakafi is a significant medical advancement for
people living with myelofibrosis, a debilitating disease,” stated
MF is a progressive, potentially life-threatening blood cancer with limited treatment options.1 Patients with MF suffer a high disease burden characterized by bone marrow failure, enlarged spleen (splenomegaly) and debilitating symptoms including fatigue, severe itching (pruritus), night sweats, bone pain, and early satiety (a feeling of fullness), leading to impaired quality of life.2 The enlarged spleen and debilitating symptoms of MF are linked to dysregulated signaling in the Janus kinase (JAK) pathway.3,4
“We are very excited about the first
Phase III Clinical Trial Data
The COMFORT-I trial, conducted by
The COMFORT-II trial, conducted by
The most common adverse reactions in both studies were thrombocytopenia and anemia. These events were manageable and rarely led to discontinuation of Jakafi treatment. The most common non-hematologic adverse reactions were bruising, dizziness, and headache.
Indication, Usage and Dosing
Jakafi is indicated for treatment of patients with intermediate or high-risk myelofibrosis, including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. Intermediate and high-risk MF patients include anyone over the age of 65 or who have or have had any of the following: anemia, constitutional symptoms, elevated white blood cell or blast counts or platelet counts less than 100 X 109/L.1,5
The recommended starting dose for most patients is either 15 mg or 20 mg given orally twice daily based on the patient’s platelet count. Dosage should be adjusted based on safety and efficacy. A blood cell count must be performed before initiating therapy with Jakafi and complete blood counts should be monitored every 2-4 weeks until doses are stabilized.
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 less than 200 X 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 X 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.
Patient Assistant Program: IncyteCARES
Jakafi will be available in
Myelofibrosis (MF) is a potentially life-threatening blood cancer that
belongs to a group of diseases referred to as myeloproliferative
neoplasms (or MPNs). MF has a poor prognosis and limited treatment
options.1 While the exact prevalence of MF is uncertain, and
estimates vary widely, based on extensive market research,
The primary mission of the
About the Incyte-Novartis Collaboration
Conference Call Information
If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference account number 278 and the identification number 383585.
The conference call will also be webcast live and can be accessed at www.incyte.com under Investor Relations, Events and Webcasts.
Except for the historical information contained herein, the matters set
forth in this press release, including statements with respect to Jakafi
having the potential to transform the way physicians treat myelofibrosis
and Jakafi being available in
These forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially, including
unanticipated developments in and risks related to the efficacy or
safety of Jakafi, the results of further research and development, the
acceptance of Jakafi in the marketplace, risks related to market
competition, risks and uncertainties associated with sales, marketing
and distribution requirements, risks associated with Incyte’s dependence
on its third party manufacturers and other risks detailed from time to
Links to third party websites or pages are provided for convenience
Cervantes F, Dupriez B, Pereira A, et al. New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and Treatment. Blood. 2009;113:2895-2901.
Mesa RA, Niblack J, Wadleigh M, et al. The burden of fatigue and quality of life in myeloproliferative disorders (MPDs): an international internet-based survey of 1179 MPD patients. Cancer. 2007;109:68-76.
Levine RL, Pardanani A, Tefferi A, Gilliland DG. Role of JAK2 in the pathogenesis and therapy of myeloproliferative disorders. Nat Rev Cancer. 2007;7:673-683.
Vannucchi AM, Guglielmelli P, Tefferi A. Advances in understanding and management of myeloproliferative neoplasms. CA Cancer J Clin. 2009;59:171-191.
Gangat N, Caramazza D, Vaidya R, et al. DIPSS Plus: A Refined Dynamic International Prognostic Scoring System for Primary Myelofibrosis That Incorporates Prognostic Information From Karyotype, Platelet Count, and Transfusion Status. J Clin Oncol. 2011;29(4):392-397.
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Pamela M. Murphy
Vice President, Investor Relations/Corporate Communications
Sam Brown Inc.
Mariesa Kemble, 608-850-4745