Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug
Administration (FDA) has accepted for Priority Review the
supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®)
for treatment of steroid-refractory chronic graft-versus-host
disease (GVHD) in adult and pediatric patients 12 years and
older.
The sNDA submission is based on results from the Phase 3,
randomized REACH3 study comparing ruxolitinib with best available
therapy (BAT) in patients with steroid-refractory chronic GVHD. In
the REACH3 study, which was recently presented at the 62nd American
Society of Hematology (ASH) Annual Meeting & Exposition,
patients treated with ruxolitinib experienced a significantly
greater overall response rate (ORR) compared to BAT at Week 24, the
primary endpoint (49.7% vs. 25.6%; p<0.0001). For the key
secondary endpoints, ruxolitinib was associated with a longer
median failure-free survival (FFS) than BAT at Week 24 (not reached
vs. 5.7 months; hazard ratio (HR), 0.370; p<0.0001), and greater
symptom improvement per the modified Lee Symptom Scale (mLSS) at
Week 24 (24.2% vs. 11.0%; odds ratio (OR), 2.62; p=0.0011). The
best ORR for patients receiving ruxolitinib was 76.4%. No new
safety signals were observed, and adverse events were consistent
with the known safety profile of ruxolitinib.
“Chronic GVHD is a life-threatening complication following stem
cell transplant that burdens a vulnerable patient population, which
today has limited treatment options,” said Peter Langmuir, M.D.,
Group Vice President, Oncology Targeted Therapies, Incyte. “The
acceptance of this sNDA represents an important milestone for
Incyte as we continue our work towards helping more people living
with GVHD, particularly for those who do not respond to steroids.
We look forward to working closely with the FDA to bring this
innovative therapy to patients and to providing continued support
to the GVHD community in the United States.”
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, 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
after 100 days of transplant1. Both forms can affect multiple organ
systems, including the skin, gastrointestinal (digestive) tract and
liver.
The FDA grants Priority Review to medicines that may offer a
major advance in treatment where none currently exists. This
designation shortens the review period to six months compared to 10
months for Standard Review. The Prescription Drug User Fee Act
(PDUFA) target action date for Jakafi in steroid-refractory chronic
GVHD is June 22, 2021.
The sNDA is also being reviewed as part of the Project Orbis
program, an initiative of the U.S. FDA Oncology Center of
Excellence that provides a framework for concurrent submission and
review of oncology drugs among international regulatory agencies.
Participating countries for this application include Canada,
Australia, Switzerland, Brazil and the United Kingdom.
In 2019, Jakafi was approved by the U.S. Food and Drug
Administration for the treatment of steroid-refractory acute GVHD
in adult and pediatric patients 12 years and older2.
About REACH3
REACH3 (NCT03112603), a randomized, open-label, multicenter
Phase 3 study sponsored by Novartis and conducted in collaboration
with and co-funded by Incyte, is evaluating the safety and efficacy
of ruxolitinib compared with best available therapy in patients
with steroid-refractory chronic GVHD.
The primary endpoint is overall response rate (ORR) at Week 24
(i.e., Cycle 7, Day 1), defined as the percentage of participants
demonstrating a complete or partial response. Key secondary
endpoints include failure-free survival (FFS) and change in the
modified Lee Symptom Scale (mLSS) score at Week 24. Other secondary
endpoints include best overall response (BOR), duration of response
(DoR), overall survival (OS), and safety. For more information
about the study, please visit
https://clinicaltrials.gov/ct2/show/NCT03112603.
About REACH
The REACH clinical trial program evaluating ruxolitinib in
patients with steroid-refractory GVHD includes the randomized
pivotal Phase 3 REACH2 and REACH3 trials, conducted in
collaboration with Novartis.
The REACH program was initiated with the Incyte-sponsored REACH1
trial, a prospective, open-label, single-cohort, multicenter,
pivotal Phase 2 trial (NCT02953678) evaluating Jakafi in
combination with corticosteroids in patients with
steroid-refractory grade II-IV acute GVHD. For more information
about the study, including trial results, please visit
https://clinicaltrials.gov/show/NCT02953678.
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
U.S. FDA for the 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 the treatment of
steroid-refractory acute GVHD in adult and pediatric patients 12
years and older.
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: for
certain types of MF and PV - low platelet or low red blood cell
counts, bruising, dizziness, headache, and diarrhea; and for acute
GVHD – low platelet, red or white blood cell counts, infections,
and fluid retention.
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, have a high
level of fat in your blood (high blood cholesterol or
triglycerides), 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.
Women should not take Jakafi while pregnant or planning to
become pregnant. Do not breast-feed during treatment with Jakafi
and for 2 weeks after the final dose.
Full Prescribing Information, which includes a more complete
discussion of the risks associated with Jakafi, is available at
www.jakafi.com.
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 the Company’s ongoing clinical development program for
ruxolitinib, the REACH program and the Company’s GVHD program
generally, and whether and when ruxolitinib will be approved for
use in the U.S. or elsewhere for steroid-refractory chronic GVHD or
any other indication, 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; determinations made by the FDA; 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, 2020. The
Company disclaims any intent or obligation to update these
forward-looking statements.
1 Ferrara JL., et al. Graft-versus-host disease. Lancet.
2009;373(9674):1550-1561. 2 Jakafi (ruxolitinib) tablets:
Prescribing Information. U.S. Food and Drug Administration; January
2020.
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version on businesswire.com: https://www.businesswire.com/news/home/20210222005224/en/
Incyte Contacts:
Media: Jenifer Antonacci Senior Director, Public Affairs
Tel: +1 302 498 7036 jantonacci@incyte.com
Kristen Griffiths Senior Manager, Public Affairs Tel: +1 302 498
7012 kgriffiths@incyte.com
Investor: Christine Chiou Senior Director, Investor
Relations Tel: +1 302 274 4773 cchiou@incyte.com
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