TARRYTOWN, N.Y. and
PARIS, July
1, 2019 /PRNewswire/ --
Libtayo is the only treatment approved in the EU for adult
patients with metastatic or locally advanced cutaneous squamous
cell carcinoma who are not candidates for curative surgery or
curative radiation
CSCC is one of the most common skin cancers worldwide and is
especially difficult to treat in advanced stages
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that the European Commission (EC) has granted
conditional marketing authorization for Libtayo®
(cemiplimab) for the treatment of adults with metastatic or locally
advanced cutaneous squamous cell carcinoma (CSCC) who are not
candidates for curative surgery or curative radiation. Libtayo is a
fully-human monoclonal antibody targeting the immune checkpoint
receptor PD-1 (programmed cell death protein-1) and is the only
treatment approved in advanced CSCC in the European Union
(EU).
"With no other medical treatments approved for advanced CSCC in
the EU, Libtayo represents an important new option for patients
affected with this advanced skin cancer who cannot be cured by
surgery or radiation," said Axel
Hauschild, M.D., Ph.D., an investigator in the pivotal CSCC
clinical program and Professor and Head of the Interdisciplinary
Skin Cancer Center at the University Hospital Schleswig-Holstein in
Kiel, Germany. "Results from the
Libtayo pivotal trial are very encouraging and demonstrated
substantial and durable responses following Libtayo treatment,
including in the elderly and regardless of PD-L1 expression
levels."
Updated data from the registrational EMPOWER-CSCC-1 trial were
recently shared at the 2019 American Society of Clinical
Oncology Annual Meeting.
CSCC is one of the most commonly diagnosed skin cancers
worldwide, and its incidence is estimated to be substantially
increasing in some European countries. Although the vast majority
of patients with CSCC have a good prognosis when discovered early,
the cancer can be especially difficult to treat when it progresses
to advanced stages. Advanced CSCC includes both patients with
locally advanced disease (where the cancer cannot be cured by
surgery and/or radiation) and patients with metastatic disease
(when the cancer spreads to other parts of the body). Based upon
historical data, patients with advanced CSCC have a life expectancy
of approximately one year.
The EC approval is based on data from the pivotal,
open-label, multi-center, non-randomized Phase 2 trial known as
EMPOWER-CSCC-1 (Study 1540) and supported by two advanced CSCC
expansion cohorts from a multi-center, open-label, non-randomized
Phase 1 trial (Study 1423). These trials provide the largest
prospective clinical data set evaluating a systemic therapy in
patients with advanced CSCC to date.
The recommended dose of Libtayo is 350 mg every 3 weeks
administered by intravenous infusion over 30 minutes. Treatment may
be continued until disease progression or unacceptable
toxicity.
The conditional approval recognizes the extreme unmet need in
advanced CSCC. As part of the conditional approval, Regeneron and
Sanofi will add a new patient group to EMPOWER-CSCC-1 to further
support the benefit-risk profile of Libtayo, and report the results
to the European Medicines Agency (EMA). As is standard practice for
conditional approvals, the EMA reviews new information at least
every year and updates product labeling as necessary.
Libtayo is being jointly developed by Regeneron and Sanofi under
a global collaboration agreement. Libtayo was invented by Regeneron
using the company's proprietary VelocImmune®
technology that yields optimized fully-human antibodies.
About Libtayo
In addition to the EU, Libtayo is also
approved in the U.S., Canada and
Brazil for adult patients with
metastatic CSCC or locally advanced CSCC who are not candidates for
curative surgery or curative radiation. In the U.S., the generic
name for Libtayo is cemiplimab-rwlc, with rwlc as the suffix
designated in accordance with Nonproprietary Naming of Biological
Products Guidance for Industry issued by the U.S. Food and Drug
Administration.
Beyond the ongoing EMPOWER-CSCC-1 trial, Libtayo is also being
investigated in adjuvant and neoadjuvant trials in CSCC and in
potential registrational trials in non-small cell lung cancer,
basal cell carcinoma and cervical cancer. Additional studies
include trials in squamous cell carcinoma of the head and neck,
melanoma, colorectal cancer, prostate cancer, multiple myeloma,
Hodgkin's lymphoma and non-Hodgkin's lymphoma. These trials are
designed to investigate Libtayo as monotherapy; in combination with
conventional treatments like chemotherapy; or in combination with
other investigational agents, including vaccines, oncolytic viruses
and bispecific antibodies, among others. These potential uses are
investigational, and their safety and efficacy have not been
evaluated by any regulatory authority.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S.
PATIENTS
What is the most important information I should know about
Libtayo?
Libtayo is a medicine that may treat a type of skin
cancer 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.
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 symptoms of the following problems or these symptoms
get worse:
- Lung problems (pneumonitis). Signs and
symptoms of pneumonitis may include new or worsening cough,
shortness of breath, and chest pain.
- Intestinal problems (colitis) that can lead to tears or
holes in your intestine. Signs and symptoms of
colitis may include diarrhea (loose stools) or more frequent bowel
movements than usual; stools that are black, tarry, sticky or that
have blood or mucus; and severe stomach-area (abdomen) pain or
tenderness.
- Liver problems (hepatitis). Signs and
symptoms of hepatitis may include yellowing of your skin or the
whites of your eyes, severe nausea or vomiting, pain on the right
side of your stomach area (abdomen), drowsiness, dark urine (tea
colored), bleeding or bruising more easily than normal, and feeling
less hungry than usual.
- Hormone gland problems (especially the adrenal glands,
pituitary, thyroid and pancreas). Signs and symptoms that your
hormone glands are not working properly may include headaches that
will not go away or unusual headaches, rapid heartbeat, increased
sweating, extreme tiredness, weight gain or weight loss, dizziness
or fainting, feeling more hungry or thirsty than usual, hair loss,
feeling cold, constipation, deeper voice, very low blood pressure,
urinating more often than usual, nausea or vomiting, stomach-area
(abdomen) pain, and changes in mood or behavior, such as decreased
sex drive, irritability, or forgetfulness.
- Kidney problems, including nephritis and kidney failure.
Signs of these problems may include decrease in your amount of
urine, blood in your urine, swelling in your ankles, and loss of
appetite.
- Skin problems. Signs of these problems may include rash,
itching, skin blistering, and painful sores or ulcers in the mouth,
nose, throat, or genital area.
- Problems in other organs. Signs of these problems may
include headache, tiredness or weakness, sleepiness, changes in
heartbeat (such as beating fast, seeming to skip a beat, or a
pounding sensation), confusion, fever, muscle weakness, balance
problems, nausea, vomiting, stiff neck, memory problems, seizures
(encephalitis), swollen lymph nodes, rash or tender lumps on skin,
cough, shortness of breath, vision changes, or eye pain
(sarcoidosis), seeing or hearing things that are not there
(hallucinations), severe muscle weakness, low red blood cells
(anemia), bruises on the skin or bleeding, and changes in
eyesight.
- Rejection of a transplanted organ. Your doctor should
tell you what signs and symptoms you should report and monitor you,
depending on the type of organ transplant that you have had.
- Infusion (IV) reactions that can sometimes be severe
and life-threatening. Signs of these problems may include
chills or shaking, itching or rash, flushing, shortness of breath
or wheezing, dizziness, fever, feeling of passing out, back or neck
pain, and facial swelling.
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 delay or completely stop treatment 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 had an organ transplant;
- have lung or breathing problems;
- have liver or kidney problems;
- have diabetes;
- 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 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.
For more information, please see full Prescribing
Information, including Medication Guide.
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.
It is not known if Libtayo is safe and effective in
children.
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for 30 years by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to seven FDA-approved treatments and numerous
product candidates in development, 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, neuromuscular
diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and 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.
About Sanofi
Sanofi is dedicated to supporting people
through their health challenges. We are a global biopharmaceutical
company focused on human health. We prevent illness with vaccines,
provide innovative treatments to fight pain and ease suffering. We
stand by the few who suffer from rare diseases and the millions
with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
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 nature, timing, and
possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation
Libtayo® (cemiplimab) Injection for the treatment of
adults with metastatic or locally advanced cutaneous squamous cell
carcinoma who are not candidates for curative surgery or curative
radiation and other potential indications; whether any product
labelling or other changes may be required by the European
Medicines Agency in the future in connection with the conditional
approval for Libtayo discussed in this press release; the
likelihood and timing of achieving any of Regeneron's anticipated
clinical development milestones; unforeseen safety issues resulting
from the administration of products and product candidates in
patients, including serious complications or side effects in
connection with the use of Regeneron's product candidates (such as
Libtayo) in clinical trials; the likelihood and timing of possible
regulatory approval and commercial launch of Regeneron's late-stage
product candidates and new indications for marketed products,
including without limitation any possible regulatory approval of
Libtayo (as a monotherapy or in combination with conventional
treatments or other investigational agents, as applicable) for the
treatment of non-small cell lung cancer, basal cell carcinoma,
cervical cancer, squamous cell carcinoma of the head and neck,
melanoma, colorectal cancer, prostate cancer, multiple myeloma,
Hodgkin's lymphoma, non-Hodgkin's lymphoma, and other potential
indications; the extent to which the results from the research and
development programs conducted by Regeneron or its collaborators
may be replicated in other studies and lead to therapeutic
applications; ongoing regulatory obligations and oversight
impacting Regeneron's marketed products (such as Libtayo), research
and clinical programs, and business, including those relating to
patient privacy; 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 product candidates; competing drugs and product
candidates that may be superior to Regeneron's products and product
candidates; uncertainty of market acceptance and commercial success
of Regeneron's products and product candidates; the ability of
Regeneron to manufacture and manage supply chains for multiple
products and product candidates; the ability of Regeneron's
collaborators, suppliers, or other third parties (as applicable) to
perform manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's products and
product candidates; the availability and extent of reimbursement of
the Company'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; 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, Bayer, and Teva
Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated without
any further product success; 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)
Injection, and Praluent® (alirocumab) Injection, the
ultimate outcome of any such proceedings, 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 fiscal year ended December
31, 2018 and its Form 10-Q for the quarterly period ended
March 31, 2019. 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 any forward-looking
statement, 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).
Sanofi Forward-Looking Statements
This press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
statements are generally identified by the words "expects",
"anticipates", "believes", "intends", "estimates", "plans" and
similar expressions. Although Sanofi's management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic
conditions, as well as those risks discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under "Risk Factors" and "Cautionary Statement
Regarding Forward-Looking Statements" in Sanofi's annual report on
Form 20-F for the year ended December 31,
2018. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
Regeneron
Contacts:
|
Sanofi
Contacts:
|
Media
Relations
Daren Kwok
Tel: +1 (914)
847-1328
daren.kwok@regeneron.com
Investor
Relations
Justin
Holko
Tel: +1 (914)
847-7786
Justin.Holko@regeneron.com
|
Media
Relations
Ashleigh
Koss
Tel: +1 (908)
981-8745
ashleigh.koss@sanofi.com
Investor
Relations
George
Grofik
Tel.: +33 (0)1 53 77
45 45
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.