TARRYTOWN, N.Y., Dec. 23,
2022 /PRNewswire/ -- Regeneron Pharmaceuticals
(NASDAQ: REGN) today announced that the Ministry of Health, Labor
and Welfare (MHLW) in Japan has
granted marketing and manufacturing authorization for
Libtayo® (cemiplimab) as monotherapy to treat patients
with advanced or recurrent cervical cancer whose disease progressed
after chemotherapy.
"In recent years, the incidence of cervical cancer has increased
in Japan, with the prognosis for
advanced stage disease remaining poor and treatment options
limited," said Israel Lowy, M.D.,
Ph.D., Senior Vice President, Translational and Clinical Sciences,
Oncology at Regeneron. "With this approval, Libtayo becomes
the first single-agent immunotherapy approved in Japan for the treatment of advanced cervical
cancer."
The MHLW approval is based on positive data from the
international, multicenter Phase 3 EMPOWER-Cervical 1 trial,
conducted in collaboration with NRG Oncology-Japan, the GOG
Foundation, Inc., and the European Network for Gynaecological
Oncological Trial (ENGOT) groups. The trial evaluated Libtayo
compared to an investigator's choice of chemotherapy and enrolled
608 patients across 14 countries, including Japan, irrespective of PD-L1 expression status
or histology. In March 2021, the
trial was stopped early based on the highly significant effect of
Libtayo on overall survival among squamous cell carcinoma patients
following a unanimous recommendation by the Independent Data
Monitoring Committee.
"With Libtayo, Japan now has an
approved treatment option that has demonstrated significant
survival benefits in this cervical cancer patient population
compared to chemotherapy irrespective of PD-L1 expression – a
milestone no other PD-1 inhibitor has achieved in a Phase 3 trial,"
said Prof. Kosei Hasegawa,
Gynecologic Oncology, Saitama Medical University International
medical Center, a trial investigator and a member of NRG
Oncology-Japan. "We are proud to have contributed to bringing
this new treatment option to women living with this
difficult-to-treat cancer in Japan.
Cervical cancer is the fourth leading cause of cancer death in
women worldwide and is most frequently diagnosed in women between
the ages of 35 and 44. Almost all cases of cervical cancer are
caused by human papillomavirus (HPV) infection. It is estimated
that approximately 600,000 new cases of cervical cancer are
diagnosed and 350,000 deaths from cervical cancer occur worldwide
each year.
In November 2022, Libtayo was
approved by the European Commission for the treatment of adult
patients with recurrent or metastatic cervical cancer and disease
progression on or after platinum-based chemotherapy.
About Libtayo
Libtayo is a fully human monoclonal
antibody targeting the immune checkpoint receptor PD-1 on T cells
and was invented using Regeneron's proprietary
VelocImmune® technology. By binding to PD-1,
Libtayo has been shown to block cancer cells from using the PD-1
pathway to suppress T-cell activation. In the U.S. and
other countries Libtayo is indicated in certain patients with
advanced basal cell carcinoma (BCC), advanced CSCC and advanced
non-small cell lung cancer (NSCLC), as well as in advanced cervical
cancer in Japan, the European Union,
Canada and Brazil.
Libtayo was jointly developed by Sanofi and Regeneron under a
global collaboration agreement. As of July
1, 2022, Regeneron is responsible for the development and
marketing of Libtayo globally. In Japan, Libtayo is currently marketed by Sanofi
on Regeneron's behalf over the course of a defined transition
period.
The extensive clinical program for Libtayo is focused on
difficult-to-treat cancers. Libtayo is currently being investigated
in trials as a monotherapy, as well as in combination with either
conventional or novel therapeutic approaches for other solid tumors
and blood cancers. These potential uses are investigational,
and their safety and efficacy have not been evaluated by any
regulatory authority.
U.S. FDA-approved Indications
Libtayo is a
prescription medicine used to treat:
-- People with a type of skin cancer called CSCC
that has spread or cannot be cured by surgery or radiation.
-- People with a type of skin cancer called
BCC:
- That cannot be removed by surgery (locally advanced BCC) and
have received treatment with a hedgehog pathway inhibitor (HHI), or
cannot receive treatment with an HHI.
- That has spread (metastatic BCC) and have received treatment
with an HHI, or cannot receive treatment with an HHI. This use is
approved based on how many patients responded to treatment and how
long they responded. Studies are ongoing to provide additional
information about clinical benefit.
-- Adults with a type of lung cancer called
NSCLC:
- Libtayo may be used in combination with chemotherapy that
contains a platinum medicine as your first treatment when your lung
cancer has not spread outside your chest (locally advanced lung
cancer) and you cannot have surgery or chemotherapy with radiation,
OR your lung cancer has spread to other areas of your body
(metastatic lung cancer), AND your tumor does not have an abnormal
"EGFR", "ALK" or "ROS1" gene.
- Libtayo may be used alone as your first treatment when your
lung cancer has not spread outside your chest (locally advanced
lung cancer) and you cannot have surgery or chemotherapy with
radiation, OR your lung cancer has spread to other areas of your
body (metastatic lung cancer), AND your tumor tests positive for
high "PD-L1", AND your tumor does not have an abnormal "EGFR", "ALK
"or "ROS1" gene.
It is not known if Libtayo is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
FOR U.S. PATIENTS
What is the most important information I should know about
Libtayo?
Libtayo is a medicine that may treat certain
cancers by working with your immune system. Libtayo can cause your
immune system to attack normal organs and tissues in any area of
your body and can affect the way they work. These problems can
sometimes become severe or life-threatening and can lead to death.
You can have more than one of these problems at the same time.
These problems may happen anytime during treatment or even after
your treatment has ended.
Call or see your healthcare provider right away if you
develop any new or worsening signs or symptoms, including:
- Lung problems: cough, shortness of breath, or chest
pain
- Intestinal problems: diarrhea (loose stools) or
more frequent bowel movements than usual, stools that are black,
tarry, sticky or have blood or mucus, or severe stomach area
(abdomen) pain or tenderness
- Liver problems: yellowing of your skin or the
whites of your eyes, severe nausea or vomiting, pain on the right
side of your stomach area (abdomen), dark urine (tea colored), or
bleeding or bruising more easily than normal
- Hormone gland problems: headache that will not go
away or unusual headaches, eye sensitivity to light, eye problems,
rapid heartbeat, increased sweating, extreme tiredness, weight gain
or weight loss, feeling more hungry or thirsty than usual,
urinating more often than usual, hair loss, feeling cold,
constipation, your voice gets deeper, dizziness or fainting, or
changes in mood or behavior, such as decreased sex drive,
irritability, or forgetfulness
- Kidney problems: decrease in your amount of urine,
blood in your urine, swelling of your ankles, or loss of
appetite
- Skin problems: rash, itching, skin blistering or
peeling, painful sores or ulcers in mouth or nose, throat, or
genital area, fever or flu-like symptoms, or swollen lymph
nodes
- Problems can also happen in other organs and tissues. These
are not all of the signs and symptoms of immune system problems
that can happen with Libtayo. Call or see your healthcare provider
right away for any new or worsening signs or symptoms, which may
include: chest pain, irregular heartbeat, shortness of
breath or swelling of ankles, confusion, sleepiness, memory
problems, changes in mood or behavior, stiff neck, balance
problems, tingling or numbness of the arms or legs, double vision,
blurry vision, sensitivity to light, eye pain, changes in eyesight,
persistent or severe muscle pain or weakness, muscle cramps, low
red blood cells, or bruising
- Infusion reactions that can sometimes be
severe. Signs and symptoms of infusion reactions may
include: nausea, chills or shaking, itching or rash, flushing,
shortness of breath or wheezing, dizziness, feel like passing out,
fever, back or neck pain, or facial swelling
- Rejection of a transplanted organ. Your healthcare
provider should tell you what signs and symptoms you should report
and monitor you, depending on the type of organ transplant that you
have had
- Complications, including graft-versus-host disease (GVHD),
in people who have received a bone marrow (stem cell) transplant
that uses donor stem cells (allogeneic). These
complications can be serious and can lead to death. These
complications may happen if you underwent transplantation either
before or after being treated with Libtayo. Your healthcare
provider will monitor you for these complications
Getting medical treatment right away may help keep these
problems from becoming more serious. Your healthcare
provider will check you for these problems during your treatment
with Libtayo. Your healthcare provider may treat you with
corticosteroid or hormone replacement medicines. Your healthcare
provider may also need to delay or completely stop treatment with
Libtayo if you have severe side effects.
Before you receive Libtayo, tell your healthcare provider
about all your medical conditions, including if you:
-- have immune system problems such as Crohn's
disease, ulcerative colitis, or lupus
-- have received an organ transplant
-- have received or plan to receive a stem cell
transplant that uses donor stem cells (allogeneic)
-- have received radiation treatment to your chest
area
-- have a condition that affects your nervous
system, such as myasthenia gravis or Guillain-Barré syndrome
-- are pregnant or plan to become pregnant. Libtayo
can harm your unborn baby
Females who are able to become
pregnant:
- Your healthcare provider will give you a pregnancy test before
you start treatment.
- You should use an effective method of birth control during your
treatment and for at least 4 months after your last dose of
Libtayo. Talk with your healthcare provider about birth control
methods that you can use during this time.
- Tell your healthcare provider right away if you become pregnant
or think you may be pregnant during treatment with Libtayo.
-- are breastfeeding or plan to breastfeed. It is
not known if Libtayo passes into your breast milk. Do not
breastfeed during treatment and for at least 4 months after the
last dose of Libtayo.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
The most common side effects of Libtayo when used alone include
muscle or bone pain, tiredness, rash, and diarrhea. The most common
side effects of Libtayo when used in combination with
platinum-containing chemotherapy include hair loss, muscle or bone
pain, nausea, tiredness, numbness, pain, tingling, or burning in
your hands or feet, decreased appetite. These are not all the
possible side effects of Libtayo. Call your doctor for medical
advice about side effects. You may report side effects to FDA at
1-800-FDA-1088. You may also report side effects to Regeneron
Pharmaceuticals at 1-877-542-8296.
Please see full Prescribing Information,
including Medication Guide.
About Regeneron in Oncology
At Regeneron, we're
applying more than three decades of scientific innovation with the
goal of developing paradigm-changing therapies for patients with
cancer. Our oncology portfolio is built around two foundational
approaches – our approved PD-1 inhibitor Libtayo and
investigational bispecific antibodies – which are being evaluated
both as monotherapies and in combination with emerging therapeutic
modalities. Together, they provide us with unique combinatorial
flexibility to develop potentially synergistic treatments for a
wide range of solid tumors and blood cancers.
If you are interested in learning more about our clinical
trials, please contact us (clinicaltrials@regeneron.com or
844-734-6643) or visit our clinical trials website.
About Regeneron's VelocImmune
Technology
Regeneron's VelocImmune technology
utilizes a proprietary genetically engineered mouse platform
endowed with a genetically humanized immune system to produce
optimized fully human antibodies. When Regeneron's co-Founder,
President and Chief Scientific Officer George D. Yancopoulos was a graduate student
with his mentor Frederick W. Alt in
1985, they were the first to envision making such a genetically
humanized mouse, and Regeneron has spent decades inventing and
developing VelocImmune and related
VelociSuite® technologies. Dr. Yancopoulos and
his team have used VelocImmune technology to create
approximately one in five of all original, FDA-approved or
authorized fully human monoclonal antibodies. This includes
REGEN-COV® (casirivimab and imdevimab),
Dupixent® (dupilumab), Libtayo, Praluent®
(alirocumab), Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and
odesivimab-ebgn).
About Regeneron
Regeneron is a leading biotechnology
company that invents, develops and commercializes life-transforming
medicines for people with serious diseases. Founded and led for
nearly 35 years by physician-scientists, our unique ability to
repeatedly and consistently translate science into medicine has led
to nine FDA-approved treatments and numerous product candidates in
development, almost all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, hematologic
conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary VelociSuite
technologies, such as VelocImmune, which uses unique
genetically humanized mice to produce optimized fully human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics
Center®, which is conducting one of the largest genetics
sequencing efforts in the world.
For more information, please visit www.Regeneron.com or follow
@Regeneron on Twitter.
Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking statements that
involve risks and uncertainties relating to future events and the
future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron"
or the "Company"), and actual events or results may differ
materially from these forward-looking statements. Words such as
"anticipate," "expect," "intend," "plan," "believe," "seek,"
"estimate," variations of such words, and similar expressions are
intended to identify such forward-looking statements, although not
all forward-looking statements contain these identifying words.
These statements concern, and these risks and uncertainties
include, among others, the impact of SARS-CoV-2 (the virus that has
caused the COVID-19 pandemic) on Regeneron's business and its
employees, collaborators, and suppliers and other third parties on
which Regeneron relies, Regeneron's and its collaborators' ability
to continue to conduct research and clinical programs, Regeneron's
ability to manage its supply chain, net product sales of products
marketed or otherwise commercialized by Regeneron and/or its
collaborators or licensees (collectively, "Regeneron's Products"),
and the global economy; the nature, timing, and possible success
and therapeutic applications of Regeneron's Products and product
candidates being developed by Regeneron and/or its collaborators or
licensees (collectively, "Regeneron's Product Candidates") and
research and clinical programs now underway or planned, including
without Libtayo® (cemiplimab) for the treatment of
patients with recurrent or metastatic cervical cancer whose disease
progressed on or after chemotherapy; uncertainty of the
utilization, market acceptance, and commercial success of
Regeneron's Products and Regeneron's Product Candidates and the
impact of studies (whether conducted by Regeneron or others and
whether mandated or voluntary), including the studies discussed or
referenced in this press release, on any of the foregoing; the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron's Product Candidates and new
indications for Regeneron's Products, such as Libtayo (as a
monotherapy or in combination with conventional or novel
therapeutic approaches, as applicable) for other solid tumors and
blood cancers as well as Regeneron's investigational bispecific
antibodies referenced in this press release; safety issues
resulting from the administration of Regeneron's Products (such as
Libtayo) and Regeneron's Product Candidates in patients, including
serious complications or side effects in connection with the use of
Regeneron's Products and Regeneron's Product Candidates in clinical
trials; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron's
ability to continue to develop or commercialize Regeneron's
Products and Regeneron's Product Candidates; ongoing regulatory
obligations and oversight impacting Regeneron's Products, research
and clinical programs, and business, including those relating to
patient privacy; the availability and extent of reimbursement of
Regeneron's Products (such as Libtayo) from third-party payers,
including private payer healthcare and insurance programs, health
maintenance organizations, pharmacy benefit management companies,
and government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to, or more cost effective than,
Regeneron's Products and Regeneron's Product Candidates; the extent
to which the results from the research and development programs
conducted by Regeneron and/or its collaborators or licensees
(including those discussed or referenced in this press release) may
be replicated in other studies and/or lead to advancement of
product candidates to clinical trials or therapeutic applications;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; the ability of
Regeneron's collaborators, licensees, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
finishing, packaging, labeling, distribution, and other steps
related to Regeneron's Products and Regeneron's Product Candidates;
unanticipated expenses; the costs of developing, producing, and
selling products; the ability of Regeneron to meet any of its
financial projections or guidance and changes to the assumptions
underlying those projections or guidance; the potential for any
license or collaboration agreement, including Regeneron's
agreements with Sanofi and Bayer (or their respective affiliated
companies, as applicable), to be cancelled or terminated; and risks
associated with intellectual property of other parties and pending
or future litigation relating thereto (including without limitation
the patent litigation and other related proceedings relating to
EYLEA® (aflibercept) Injection, Praluent®
(alirocumab), and REGEN-COV® (casirivimab and
imdevimab)), other litigation and other proceedings and government
investigations relating to the Company and/or its operations, the
ultimate outcome of any such proceedings and investigations, and
the impact any of the foregoing may have on Regeneron's business,
prospects, operating results, and financial condition. A more
complete description of these and other material risks can be found
in Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the
quarterly period ended September 30,
2022. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
(publicly or otherwise) any forward-looking statement, including
without limitation any financial projection or guidance, whether as
a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Contacts:
Media
Relations
Taylor
Ramsey
Tel: +1
914-409-2381
taylor.ramsey@regeneron.com
|
Investor
Relations
Vesna
Tosic
Tel: +1
914-847-5443
vesna.tosic@regeneron.com
|
View original
content:https://www.prnewswire.com/news-releases/libtayo-cemiplimab-approved-in-japan-for-advanced-or-recurrent-cervical-cancer-301709636.html
SOURCE Regeneron Pharmaceuticals, Inc.