Treatment guidelines for myeloproliferative
neoplasms (MPNs) focused on the treatment of myelofibrosis (MF), a
rare blood cancer, published today
Incyte Corporation (Nasdaq: INCY) today announced that its
first-in-class JAK1/JAK2 inhibitor, Jakafi® (ruxolitinib), has been
included as a recommended treatment in the latest National
Comprehensive Cancer Network® (NCCN®) Clinical
Practice Guidelines in Oncology for myelofibrosis (MF).
“Jakafi is the first FDA-approved treatment for patients with
intermediate or high-risk MF, representing an important advancement
for patients,” said Peg Squier, M.D., Ph.D., Incyte’s Head of U.S.
Medical Affairs. “We are pleased that Jakafi has been recommended
in the first set of NCCN treatment guidelines for MPNs, which will
help inform healthcare providers’ treatment decisions for patients
with MF. We believe that this underscores the important and
long-term clinical benefits seen in patients treated with
Jakafi.”
MF is part of a group of related rare blood cancers known as
myeloproliferative neoplasms (MPNs). In MF, a patient’s bone marrow
can no longer produce enough normal blood cells, causing the spleen
and or liver to become enlarged.1 MF is a progressive disease,
which leads to bone marrow scarring and significant debilitating
disease-related symptoms such as anemia, fatigue, and itching which
can result in a poor quality of life.2 Patients with MF have a
decreased life expectancy, with an average survival of
approximately five to six years.3 The cause of MF is unknown but is
linked to genetic mutations—between 50% and 60% of people with MF
have a specific mutation of the Janus Kinase 2 gene (JAK2).4
The new NCCN Guidelines are available online at
www.nccn.org.
About Jakafi (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
U.S. Food and Drug Administration, for treatment of people with
intermediate or high-risk myelofibrosis (MF), including primary MF,
post–polycythemia vera MF, and post–essential thrombocythemia
MF.
Jakafi is also indicated for treatment of people with
polycythemia vera (PV) who have had an inadequate response to or
are intolerant of hydroxyurea.
Jakafi is marketed by Incyte in the United States and by
Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi
is a registered trademark of Incyte Corporation. Jakavi is a
registered trademark of Novartis AG in countries outside the United
States.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi® (ruxolitinib) 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 develop or have worsening symptoms such as unusual
bleeding, bruising, tiredness, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious
infection during treatment with Jakafi. Tell your healthcare
provider if you develop any of the following symptoms of infection:
chills, nausea, vomiting, aches, weakness, fever, painful skin rash
or blisters.
Skin cancers: Some people who take Jakafi have developed
certain types of non-melanoma skin cancers. Tell your healthcare
provider if you develop any new or changing skin lesions.
Increases in Cholesterol: You may have changes in your
blood cholesterol levels. Your healthcare provider will do blood
tests to check your cholesterol levels during your treatment with
Jakafi.
The most common side effects of Jakafi include: low
platelet count, low red blood cell counts, bruising, dizziness,
headache.
These are not all the possible side effects of Jakafi. Ask your
pharmacist or healthcare provider 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 tuberculosis (TB), or have been in
close contact with someone who has TB, have or had hepatitis B,
have or had liver or kidney problems, are on dialysis, had skin
cancer or have any other medical condition. Take Jakafi exactly as
your healthcare provider tells you. Do not change or stop taking
Jakafi without first talking to your healthcare provider. Do not
drink grapefruit juice while on Jakafi.
Women should not take Jakafi while pregnant or planning to
become pregnant, or if breast-feeding.
Full Prescribing Information, which includes a more complete
discussion of the risks associated with Jakafi, is available at
www.jakafi.com.
About National Comprehensive Cancer Network
The National Comprehensive Cancer Network® (NCCN®), a
not-for-profit alliance of 27 of the world’s leading cancer centers
devoted to patient care, research, and education, is dedicated to
improving the quality, effectiveness, and efficiency of cancer care
so that patients can live better lives. Through the leadership and
expertise of clinical professionals at NCCN Member Institutions,
NCCN develops resources that present valuable information to the
numerous stakeholders in the health care delivery system. As the
arbiter of high-quality cancer care, NCCN promotes the importance
of continuous quality improvement and recognizes the significance
of creating clinical practice guidelines appropriate for use by
patients, clinicians, and other health care decision-makers.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based
biopharmaceutical company focused on the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit the Company’s website at
www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
1
Leukemia & Lymphoma Society.
“Myelofibrosis Facts.” Available at:
http://www.lls.org/sites/default/files/file_assets/FS14_Myelofibrosis_Fact%20Sheet_Final9.12.pdf.
Accessed November 2015.
2
Mesa RA, Schwagera S, Radia D, et al. The
Myelofibrosis Symptom Assessment Form (MFSAF): An Evidence-based
Brief Inventory to Measure Quality of Life and Symptomatic Response
to Treatment in Myelofibrosis. Leuk Res. 2009;33:1199-1203.
3
Gangat N, Caramazza D, Vaidya R, et al.
DIPSS-plus: A Refined Dynamic International Prognostic Scoring
System (DIPSS) for Primary Myelofibrosis that Incorporates
Prognostic Information from Karyotype, Platelet Count and
Transfusion Status. J Clin Oncol. 2011; 29:392-397.
4 Patriarca F1, Bacigalupo A, Sperotto A, et al. Allogeneic
hematopoietic stem cell transplantation in myelofibrosis: the
20-year experience of the Gruppo Italiano Trapianto di Midollo
Osseo (GITMO). Haematologica. 2008; 93:1514-1522.
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Incyte CorporationMediaCatalina Loveman+1
302-498-6171cloveman@incyte.comorInvestorsMichael Booth,
DPhil+1 302-498-5914mbooth@incyte.com
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