TARRYTOWN, N.Y., Sept. 28, 2021 /PRNewswire/ --
European Union regulatory submission planned by end of
2021
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for priority review the supplemental Biologics License
Application (sBLA) for PD-1 inhibitor Libtayo®
(cemiplimab-rwlc) to treat patients with recurrent or metastatic
cervical cancer whose disease progressed on or after chemotherapy.
The target action date for the FDA decision is January 30, 2022. The sBLA is also being reviewed
under the FDA's Project Orbis initiative, which will allow for
concurrent review by participating health authorities in
Australia, Brazil, Canada and Switzerland. Additional global regulatory
submissions are planned, including in the European Union (EU) by
the end of 2021.
The sBLA is supported by results from a Phase 3 trial that
enrolled patients irrespective of
PD-L1 expression status and is being conducted with The GOG
Foundation, Inc. (GOG), the European Network for Gynaecological
Oncological Trial groups (ENGOT) and NRG Oncology-Japan. Detailed
results were first presented as part of a European Society for
Medical Oncology (ESMO) Virtual Plenary in May 2021.
Cervical cancer is the fourth leading cause of cancer death in
women worldwide and is most frequently diagnosed in those between
the ages of 35 and 44. Almost all cases are caused by human
papillomavirus (HPV) infection, with approximately 80% classified
as squamous cell carcinoma (SCC; arising from cells lining the
bottom of the cervix) and the remainder being largely
adenocarcinomas (arising from glandular cells in the upper cervix).
Cervical cancer is often curable when detected early and
effectively managed, but treatment options are more limited in
advanced stages.
It is estimated that approximately 570,000 people are diagnosed
with cervical cancer worldwide each year, with deaths exceeding
250,000. In the U.S. there are 14,500 new cases diagnosed annually
and approximately 4,000 die each year.
Libtayo, which was invented using Regeneron's proprietary
VelocImmune® technology, is being jointly
developed by Regeneron and Sanofi under a global collaboration
agreement. The use of Libtayo in advanced cervical cancer is
investigational, and its safety and efficacy have not been fully
evaluated by any regulatory authority.
About the Phase 3 Trial
The Phase 3, open-label, multi-center trial, known as
EMPOWER-Cervical 1, is the largest randomized clinical trial in
advanced cervical cancer. The trial investigated Libtayo
monotherapy versus an investigator's choice of chemotherapy in
patients with recurrent or metastatic cervical cancer who had
progressed on platinum-based chemotherapy. Patients were enrolled
regardless of tumor PD-L1 expression status or histology in 14
countries, including the U.S., Japan, Taiwan, South
Korea, Canada, Russia, Poland, Spain, Brazil, Australia, the UK, Italy, Greece
and Belgium.
Patients (median age: 51 years) were randomized to receive
Libtayo monotherapy (350 mg every three weeks) or commonly used
chemotherapy regimens (pemetrexed, vinorelbine, topotecan,
irinotecan or gemcitabine). The primary endpoint for the trial was
overall survival, analyzed first among patients with SCC histology,
then in the total population.
About Libtayo
Libtayo is a fully human monoclonal antibody targeting the PD-1
immune checkpoint receptor on T-cells. By binding to PD-1, Libtayo
has been shown to block cancer cells from using the PD-1 pathway to
suppress T-cell activation.
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.
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 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 a quarter of all original, FDA-approved and
authorized fully human monoclonal antibodies currently available.
This includes REGEN–COV™ (casirivimab with imdevimab),
Dupixent® (dupilumab), Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab),
Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and
odesivimab-ebgn).
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S.
PATIENTS
What is Libtayo?
Libtayo is a prescription medicine used to treat people with a
type of skin cancer called cutaneous squamous cell carcinoma (CSCC)
that has spread or cannot be cured by surgery or radiation.
Libtayo is a prescription medicine used to treat people with a
type of skin cancer called basal cell carcinoma that cannot be
removed by surgery (locally advanced BCC) and have received
treatment with a hedgehog inhibitor (HHI), or cannot receive
treatment with an HHI.
Libtayo is a prescription medicine used to treat people with a
type of skin cancer called basal cell carcinoma 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.
Libtayo is a prescription medicine used to treat people with a
type of lung cancer called non-small cell lung cancer (NSCLC).
Libtayo may be used 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.
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 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 include muscle or bone
pain, tiredness, rash, and diarrhea. 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 and
Sanofi at
1-877-542-8296.
Please see full Prescribing Information,
including Medication Guide.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led for over 30 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 additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
Regeneron 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 (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
(collectively, "Regeneron's Product Candidates") and research and
clinical programs now underway or planned, including without
limitation Libtayo® (cemiplimab) for the
treatment of patients with recurrent or metastatic cervical cancer
whose disease progressed on or after chemotherapy; 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 possible regulatory approval of
Libtayo for the treatment of cervical cancer and other potential
indications, including in combination with either
conventional or novel therapeutic approaches for both solid tumors
and blood cancers; uncertainty of the utilization, market
acceptance, and commercial success of Regeneron's Products (such as
Libtayo) and Regeneron's Product Candidates and the impact
of studies (whether conducted by Regeneron or others and whether
mandated or voluntary), including the study discussed in this press
release, on any of the foregoing; the ability of Regeneron's
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perform manufacturing, filling, finishing, packaging, labeling,
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Regeneron's Product Candidates; the ability of Regeneron to
manufacture and manage supply chains for multiple products and
product candidates; 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, including without limitation Libtayo; 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 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
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in other studies and/or lead to advancement of product candidates
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Regeneron's agreements with Sanofi, Bayer, and Teva Pharmaceutical
Industries Ltd. (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, Dupixent®
(dupilumab), Praluent® (alirocumab), and
REGEN-COVTM (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, 2020 and its Form 10-Q for the
quarterly period ended June 30, 2021.
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
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Contacts:
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Relations
Daren Kwok
Tel: +1
914-847-1328
daren.kwok@regeneron.com
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Relations
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Tosic
Tel: +1
914-847-5443
vesna.tosic@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.