NEW ORLEANS -- (BUSINESS WIRE) -- Incyte Corporation (Nasdaq: INCY) announced today that more than 35 analyses from clinical studies of Jakafi® (ruxolitinib) were presented at the 2013 American Society of Hematology (ASH) Annual Meeting from Dec. 7 to 10 in New Orleans. Jakafi, an oral JAK1/JAK2 inhibitor, is FDA-approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF).
“Myelofibrosis is a debilitating, life-threatening blood cancer with limited treatment options. It is, therefore, rewarding to see that the expanding body of clinical data for Jakafi shows durable reductions in spleen volume and clinically meaningful improvements in health-related quality of life measures and supports a survival benefit for patients,” stated Paul A. Friedman, M.D., Incyte’s Chief Executive Officer and President.
Ruben Mesa, M.D., Deputy Director, Mayo Clinic Cancer Center; Chair, Division of Hematology and Medical Oncology, Mayo Clinic in Arizona; and creator of the Myelofibrosis Symptom Assessment Form, an evidence-based tool used in the COMFORT trials to measure quality of life and symptomatic response to treatment, stated, “Given the growing evidence of a potential survival benefit for Jakafi-treated patients, it’s important to note that data from COMFORT-I suggest that dose titration and close monitoring of blood counts early in the course of Jakafi treatment are more likely to help patients remain on drug therapy, achieve and maintain improvements in spleen volume and symptoms, and improve survival.”
Highlights of Key Data Presented
Other data related to Jakafi presented at ASH include:
About Jakafi® (ruxolitinib)
Jakafi is an oral, selective inhibitor of Janus kinases 1 and 2 (JAK1 and JAK2). Jakafi is indicated for treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. This life-threatening blood cancer is characterized by bone marrow failure, enlarged spleen (splenomegaly) and debilitating symptoms.
Important Safety Information
Jakafi can cause serious side effects including:
Low blood counts: Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you experience unusual bleeding, bruising, fatigue, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious infection while taking Jakafi. Tell your healthcare provider if you develop symptoms such as chills, nausea, vomiting, aches, weakness, fever, or painful skin rash or blisters.
The most common side effects of Jakafi include dizziness and headache.
These are not all the possible side effects of Jakafi. Ask your healthcare provider or pharmacist for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Before taking Jakafi, tell your healthcare provider about all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had liver or kidney problems, are on dialysis, or have any other medical condition. Do not drink grapefruit juice while taking Jakafi.
Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Please see the Full Prescribing Information available at www.jakafi.com, which includes a more complete discussion of the risks associated with Jakafi.
Jakafi is marketed as Jakavi® by Novartis outside the United States. COMFORT-I was conducted by Incyte in the United States, Canada and Australia. COMFORT-II was conducted by Novartis in Europe.
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.
Except for the historical information contained herein, the matters set forth in this press release, including statements with respect to the potential efficacy, safety and therapeutic value of Jakafi® (ruxolitinib), including statements regarding an overall survival benefit or improvement or reduction in risk of death with treatment with Jakafi and that certain data may underestimate the survival benefit, that data from COMFORT-I suggest that dose titration and close monitoring of blood counts early in the course of Jakafi treatment are more likely to help patients remain on drug therapy, achieve and maintain improvements in spleen volume and symptoms, and improve survival, that treatment with Jakafi may stabilize or improve bone marrow fibrosis in patients with myelofibrosis, and that sustained JAK1/JAK2 inhibition may be disease-modifying in myelofibrosis, contain predictions and estimates and are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are based on Incyte’s current expectations and 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 high degree of risk and uncertainty associated with drug development and clinical trials, and other risks detailed from time to time in Incyte's filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2013. Incyte disclaims any intent or obligation to update these forward-looking statements.