- The positive opinion from the CHMP is based on data from the
Phase 3 REACH2 and REACH3 trials, which demonstrated that
ruxolitinib (Jakavi®) improved response rates and failure-free
survival compared to best available therapy, which provides a
promising opportunity for patients living with graft-versus-host
disease (GvHD)1,2
- Graft-versus-host disease (GVHD) is a life-threatening
complication of stem cell transplants, with no established standard
of care in Europe for patients who do not adequately respond to
first-line steroid treatment3,4
- Nearly half of patients experience acute or chronic GVHD
following allogeneic transplants 3,4
Incyte (Nasdaq:INCY) today announced that the European Medicines
Agency’s Committee for Medicinal Products for Human Use (CHMP) has
issued a positive opinion recommending approval of ruxolitinib
(Jakavi®) for the treatment of patients aged 12 years and older
with acute graft-versus-host disease or chronic graft-versus-host
disease (GVHD) and who have inadequate response to corticosteroids
or other systemic therapies. If approved, ruxolitinib will be the
first JAK1/2 inhibitor available for patients with GVHD in Europe.4
Ruxolitinib is marketed as Jakavi by Novartis in Europe and as
Jakafi® by Incyte in the U.S.
“We are pleased that the CHMP has recommended approval of
ruxolitinib for the treatment of acute or chronic GVHD in Europe,”
said Peter Langmuir, M.D., Group Vice President, Oncology Targeted
Therapies, Incyte. “With this positive opinion, patients living
with these life-threatening complications who do not respond to
first-line steroids therapies are one step closer to having a new
potential standard of care.”
The CHMP positive opinion was based on data from the Phase 3
REACH2 and REACH3 clinical studies, in which ruxolitinib
demonstrated superiority versus best available therapy (BAT) in
patients with steroid-refractory and steroid-dependent acute and
chronic GVHD, respectively.
Results from the REACH2 trial showed an overall response rate
(ORR) at Day 28 was superior in the ruxolitinib arm at 62.3% vs.
39.4% in the BAT arm (odds ratio [OR], 2.64; p<0.001) in
patients with steroid refractory/dependent acute GVHD; and in those
patients who maintained response at Day 56, the ORR in the Jakavi
arm was 40% vs. 22% in the BAT arm (p<0.001). In REACH3,
treatment with ruxolitinib led to significant improvements in ORR
compared to BAT (49.7% vs. 25.6%; OR, 2.99; P<0.0001) in
patients with steroid refractory/dependent chronic GVHD at week 24,
the primary endpoint of the study, regardless of the individual
organs involved at baseline. Also, best overall response (BOR) rate
at any time up to week 24 was achieved in 76.4% of patients in the
ruxolitinib arm compared to 60.4% in the BAT arm (OR, 2.17; 95% CI,
1.34-3.52). Results from the two studies were published in the
April 22, 2020 (REACH2), and July 15, 2021 (REACH3) issues of The
New England Journal of Medicine.1,2
GVHD is a condition that can occur after an allogeneic stem cell
transplant (the transfer of stem cells from a donor) where the
donated cells initiate an immune response and attack the transplant
recipient’s organs, leading to significant morbidity and mortality.
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 transplant.2 GVHD can affect multiple
organ systems including the skin, gastrointestinal (digestive)
tract and liver.
“For many hematologic diseases allogeneic transplant is the only
treatment with the potential to be curative; however, half will go
on to develop acute or chronic GVHD,” said Dr. Robert Zeiser,
University Hospital Freiburg, Department of Haematology, Oncology
and Stem Cell Transplantation, Freiburg, Germany. “It is
encouraging that we may soon have a new standard of care for
patients with this often debilitating condition who do not
adequately respond to first-line corticosteroids.”
The CHMP opinion to recommend the use of ruxolitinib in acute
and chronic GVHD is now being reviewed by the European Commission,
which has the authority to grant marketing authorization for
medicinal products in the European Union. The EC will review the
CHMP recommendations and is expected to make a final decision
within approximately 2 months.
In 2019, Jakafi® (ruxolitinib) was approved by the U.S. Food and
Drug Administration (FDA) for the treatment of steroid-refractory
acute GVHD in adult and pediatric patients 12 years and older,
based on the positive results of the Phase 2 REACH1 trial.5
Additionally, in 2021, Jakafi was approved by the 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, based
on the positive results of the Phase 3 REACH3 trial.5
About Jakafi® (ruxolitinib)
Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the
U.S. FDA 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; steroid-refractory acute GVHD in adult and pediatric
patients 12 years and older; and chronic GVHD after failure of one
or two lines of systemic therapy in adult and pediatric patients 12
years and older.5
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 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 myelofibrosis (MF) and polycythemia vera (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.
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 whether and when
ruxolitinib (Jakavi®) will be approved in Europe for treatment of
acute and chronic GVHD, statements regarding the Company’s ongoing
clinical development program for ruxolitinib, the REACH program,
and the Company’s GVHD program generally, 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; 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; greater than expected expenses; expenses relating to
litigation or strategic activities; and other risks detailed from
time to time in the Company’s reports filed with the Securities and
Exchange Commission, including its annual report on Form 10-K for
the year ended December 31, 2021. The Company disclaims any intent
or obligation to update these forward-looking statements.
1 Zeiser R, et al. Ruxolitinib for Glucocorticoid-Refractory
Chronic Graft-versus-Host Disease (REACH3). New England Journal of
Medicine; July 2021. 2 Zeiser, R, et al. Ruxolitinib for
Glucocorticoid-Refractory Acute Graft-versus-Host Disease (REACH2).
New England Journal of Medicine. April 2020. 3 Leukemia and
Lymphoma Society. Graft-Versus-Host Disease Overview. 2021.
Available at:
https://www.lls.org/treatment/types-treatment/stem-cell-transplantation/graft-versus-host-disease
4 Jaglowski SM, et al. Graft-versus-Host Disease: Why Haven’t We
Made More Progress? Curr Opin Hematol. 2014;21(2):141-147 5 Jakafi
(ruxolitinib) tablets: Prescribing Information. U.S. Food and Drug
Administration.
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version on businesswire.com: https://www.businesswire.com/news/home/20220325005243/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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