- Jakafi is approved for treatment of chronic
GVHD after failure of one or two lines of systemic therapy in adult
and pediatric patients 12 years and older
- Today’s approval marks the fourth
FDA-approved indication for Jakafi, which received FDA-approval in
2019 for steroid-refractory acute GVHD in adult and pediatric
patients 12 years and older
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug
Administration (FDA) has approved Jakafi® (ruxolitinib) for
treatment of chronic graft-versus-host disease (GVHD) after failure
of one or two lines of systemic therapy in adult and pediatric
patients 12 years and older.
“GVHD is the leading cause of morbidity and mortality in
patients following an allogeneic stem cell transplant, yet there
historically have been limited treatment options available beyond
first-line systemic therapies,” stated Steven Stein, M.D., Chief
Medical Officer, Incyte. “Incyte is proud to have contributed to
the overall scientific understanding of GVHD through our REACH
program, which has led to important treatment advances on behalf of
patients and the medical community, including today’s approval of
Jakafi for certain people who develop chronic GVHD.”
The FDA approval was based on the REACH3 study, a Phase 3,
randomized, open-label, multicenter study of Jakafi in comparison
to best available therapy (BAT) for treatment of steroid-refractory
chronic GVHD after allogeneic stem cell transplantation. The
primary endpoint of overall response rate (ORR) at Week 24 (i.e.,
Cycle 7 Day 1) was 49.7% for Jakafi compared to 25.6% for BAT
(P<0.0001)1. Furthermore, the ORR through Cycle 7 Day 1 was 70%
for Jakafi compared to 57% for BAT2. The most common hematologic
adverse reactions (incidence > 35%) were anemia and
thrombocytopenia. The most common nonhematologic adverse reactions
(incidence ≥ 20%) were infections (pathogen not specified) and
viral infection. Full results from the REACH3 study were published
in the New England Journal of Medicine (NEJM).
“Nearly half of the people who develop chronic GVHD do not
respond adequately to steroids – the current standard of care –
making this life-threatening condition particularly challenging to
treat,” said Dr. Robert Zeiser, University Medical Center Freiburg,
Department of Hematology, Oncology and Stem Cell Transplantation,
Freiburg, Germany, the principal investigator of the REACH3 trial.
“In this clinical trial, treatment with Jakafi demonstrated
significantly improved outcomes across a range of efficacy measures
compared to best available therapy. This approval represents a
significant advancement in the treatment of appropriate patients
with chronic GVHD – for both the patients who face a poor prognosis
and the healthcare providers who struggle to effectively treat
them.”
GVHD is a condition that can occur after an allogeneic stem cell
transplant (the transfer of stem cells from a donor) in which the
donated cells initiate an immune response and attack the transplant
recipient’s organs. There are two major forms of GVHD: acute, which
generally occurs within 100 days of transplant, and chronic, which
generally occurs more than 100 days after transplant3. Both forms
are associated with significant morbidity and mortality and can
affect multiple organ systems.
“In the U.S., there are over 14,000 people living with chronic
GVHD, many of whom face significant complications that may impair
daily activities and linger for years,” said Susan Stewart,
Executive Director, BMT InfoNet. “The approval of Jakafi is an
exciting development for the GVHD community and an important step
forward in the treatment of a disease with few options.”
Jakafi’s supplemental New Drug Application (sNDA) in chronic
GHVD was reviewed under the FDA’s Priority Review program as well
as the Project Orbis program, an initiative of the FDA Oncology
Center of Excellence that provides a framework for concurrent
submission and review of oncology drugs among its international
partners. Participating countries for this application include
Canada, Australia, Switzerland, Brazil and the United Kingdom.
Incyte is committed to supporting patients and removing barriers
to access medicines. Eligible patients in the U.S. who are
prescribed Jakafi have access to IncyteCARES (Connecting to Access,
Reimbursement, Education and Support), a comprehensive program
offering patient support, including financial assistance and
ongoing education and resources to eligible patients. More
information about IncyteCARES is available by visiting
www.incytecares.com or calling 1-855-452-5234.
About REACH3
REACH3 (NCT03112603), a randomized, open-label, multicenter
Phase 3 study co-sponsored by Novartis and Incyte, evaluated the
safety and efficacy of ruxolitinib compared with best available
therapy (BAT) in patients with steroid-refractory chronic GVHD.
For more information about the study, please visit
https://clinicaltrials.gov/ct2/show/NCT03112603.
About Jakafi® (ruxolitinib)
Jakafi is a JAK1/JAK2 inhibitor approved by the U.S. FDA for
treatment of chronic GVHD after failure of one or two lines of
systemic therapy in adult and pediatric patients 12 years and
older.
Jakafi is also indicated for treatment of polycythemia vera (PV)
in adults who have had an inadequate response to or are intolerant
of hydroxyurea, intermediate or high-risk myelofibrosis (MF),
including primary MF, post-polycythemia vera MF and post-essential
thrombocythemia MF in adults, and for treatment of
steroid-refractory acute GVHD in adult and pediatric patients 12
years and older2.
Jakafi is marketed by Incyte in the U.S. and by Novartis as
Jakavi® (ruxolitinib) outside the U.S. Jakafi is a registered
trademark of Incyte. Jakavi is a registered trademark of Novartis
AG in countries outside the U.S.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi® (ruxolitinib) may cause low
platelet, red blood cell, and white blood cell counts. If you
develop bleeding, stop taking Jakafi and call your healthcare
provider. Your healthcare provider will do a blood test 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.
Cancer: Some people have had certain types of
non-melanoma skin cancers during treatment with Jakafi. Your
healthcare provider will regularly check your skin during your
treatment with Jakafi. Tell your healthcare provider if you develop
any new or changing skin lesions during treatment with Jakafi.
Increases in cholesterol: You may have changes in your
blood cholesterol levels during treatment with Jakafi. Your
healthcare provider will do blood tests to check your cholesterol
levels about every 8 to 12 weeks after you start taking Jakafi, and
as needed.
Increased risk of major cardiovascular events such as heart
attack, stroke or death in people who have cardiovascular risk
factors and who are current or past smokers while using another JAK
inhibitor to treat rheumatoid arthritis: Get emergency help
right away if you have any symptoms of a heart attack or stroke
while taking Jakafi, including: discomfort in the center of your
chest that lasts for more than a few minutes, or that goes away and
comes back, severe tightness, pain, pressure, or heaviness in your
chest, throat, neck, or jaw, pain or discomfort in your arms, back,
neck, jaw, or stomach, shortness of breath with or without chest
discomfort, breaking out in a cold sweat, nausea or vomiting,
feeling lightheaded, weakness in one part or on one side of your
body, slurred speech
Increased risk of blood clots: Blood clots in the veins
of your legs (deep vein thrombosis, DVT) or lungs (pulmonary
embolism, (PE) have happened in people taking another JAK inhibitor
for rheumatoid arthritis and may be life-threatening. Tell your
healthcare provider right away if you have any signs and symptoms
of blood clots during treatment with Jakafi, including: swelling,
pain, or tenderness in one or both legs, sudden, unexplained chest
or upper back pain, shortness of breath or difficulty breathing
Possible increased risk of new (secondary) cancers:
People who take another JAK inhibitor for rheumatoid arthritis have
an increased risk of new (secondary) cancers, including lymphoma
and other cancers. People who smoke or who smoked in the past have
an added risk of new cancers.
The most common side effects of Jakafi include: for
certain types of MF and PV – low platelet or red blood cell counts,
bruising, dizziness, headache, and diarrhea; for acute GVHD – low
platelet counts, low red or white blood cell counts, infections,
and swelling; and for chronic GVHD – low red blood cell or platelet
counts and infections including viral infections.
These are not all the possible side effects of Jakafi. Ask your
pharmacist or healthcare provider for more information. Call your
doctor for medical advice about side effects.
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 low white or red blood cell counts,
have or had tuberculosis (TB) or have been in close contact with
someone who has TB, had shingles (herpes zoster), have or had
hepatitis B, have or had liver or kidney problems, are on dialysis,
have high cholesterol or triglycerides, had cancer, are a current
or past smoker, had a blood clot, heart attack, other heart
problems or stroke, or have any other medical condition. Take
Jakafi exactly as your healthcare provider tells you. Do not change
your dose or stop taking Jakafi without first talking to your
healthcare provider.
Women should not take Jakafi while pregnant or planning to
become pregnant. Do not breastfeed during treatment with Jakafi and
for 2 weeks after the final dose.
Please see the Full Prescribing Information, which includes a
more complete discussion of the risks associated with
Jakafi.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
You may also report side effects to Incyte Medical Information
at 1-855-463-3463.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding whether or when Jakafi might provide a successful
treatment option for patients with steroid-refractory chronic GVHD,
the Company’s ongoing clinical development program for ruxolitinib
and the REACH clinical trial program, contain predictions,
estimates and other forward-looking statements.
These forward-looking statements are based on the Company’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: unanticipated
delays; further research and development and the results of
clinical trials possibly being unsuccessful or insufficient to meet
applicable regulatory standards or warrant continued development;
the ability to enroll sufficient numbers of subjects in clinical
trials and the ability to enroll subjects in accordance with
planned schedules; the effects of the COVID-19 pandemic and
measures to address the pandemic on the Company’s clinical trials
supply chain and other third-party providers and development and
discovery operations; determinations made by the FDA or other
regulatory authorities; the Company’s dependence on its
relationships with its collaboration partners; the efficacy or
safety of the Company’s products and the products of the Company’s
collaboration partners; the acceptance of the Company’s products
and the products of the Company’s collaboration partners in the
marketplace; market competition; sales, marketing, manufacturing
and distribution requirements; and other risks detailed from time
to time in the Company’s reports filed with the Securities and
Exchange Commission, including its annual report and its quarterly
report on Form 10-Q for the quarter ended June 30, 2021. The
Company disclaims any intent or obligation to update these
forward-looking statements.
1 Zeiser R, M.D., et al. Ruxolitinib for
Glucocorticoid-Refractory Chronic Graft-versus-Host Disease. New
England Journal of Medicine; July 2021. 2 Jakafi (ruxolitinib)
tablets: Prescribing Information. U.S. Food and Drug
Administration; September 2021. 3 Ferrara JL., et al.
Graft-versus-host disease. Lancet. 2009;373(9674):1550-1561.
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version on businesswire.com: https://www.businesswire.com/news/home/20210922005863/en/
Media Jenifer Antonacci +1 302 498 7036
jantonacci@incyte.com Kristen Griffiths +1 302 498 7012
kgriffiths@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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