TARRYTOWN, N.Y., Oct. 29, 2020 /PRNewswire/ -- 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 first-line locally advanced or metastatic
non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. The
target action date for the FDA decision is February 28, 2021.
The sBLA is supported by results from a Phase 3 open-label,
randomized, multi-center trial that investigated the first-line
treatment of Libtayo monotherapy compared to platinum-doublet
chemotherapy in patients with locally advanced or metastatic NSCLC
whose tumor cells expressed PD-L1, including those whose cancers
had confirmed PD-L1 expression of ≥50% using the PD-L1 IHC 22C3
pharmDx kit. Results were recently presented at the 2020
European Society for Medical Oncology (ESMO) Virtual Congress in
September.
The European Medicines Agency (EMA) is also assessing Libtayo in
advanced NSCLC with ≥50% PD-L1 expression and a decision is
expected in the second quarter of 2021. Libtayo is the first
systemic treatment approved in the U.S. and European Union (EU) for
adults with metastatic cutaneous squamous cell carcinoma (CSCC) or
locally advanced CSCC who are not candidates for curative surgery
or curative radiation.
Libtayo is being jointly developed and commercialized by
Regeneron and Sanofi under a global collaboration agreement. The
use of Libtayo to treat advanced NSCLC is investigational and has
not been fully evaluated by any regulatory authority.
About Non-small Cell Lung Cancer
Lung cancer is the
leading cause of cancer death worldwide, with more than 2.2 million
new cases expected globally, and 228,000 new cases expected in the
U.S. in 2020. Approximately 85% of all lung cancers are NSCLC, and
an estimated 25% to 30% of these cases are expected to test
positive for PD-L1 in ≥50% of tumor cells. While immunotherapies
have transformed advanced NSCLC treatment in recent years, there
remains an unmet need to optimize the identification and treatment
of patients with high PD-L1 expression and offer additional
treatment options.
About Libtayo
Libtayo is a fully-human monoclonal
antibody targeting the immune checkpoint receptor PD-1 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.
Libtayo was invented using Regeneron's proprietary
VelocImmune® technology that utilizes a
genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies. VelocImmune technology has been used
to create multiple antibodies including
Dupixent® (dupilumab),
Praluent® (alirocumab) and
Kevzara® (sarilumab), which are approved in
multiple countries around the world. Regeneron previously used
these technologies to rapidly develop a treatment for
Zaire ebolavirus infection,
which is approved by the FDA, and to create a potentially
preventative and therapeutic investigational medicine for COVID-19
that was recently submitted to the FDA for an Emergency Use
Authorization (EUA).
The extensive clinical program for Libtayo is focused on
difficult-to-treat cancers. In skin cancer, this includes trials in
adjuvant and neoadjuvant CSCC in addition to a pivotal trial in
advanced basal cell carcinoma. Libtayo is also being investigated
in pivotal trials in NSCLC (in combination with chemotherapy) and
cervical cancer, as well as in trials combining Libtayo with either
conventional or novel therapeutic approaches for both solid tumors
and blood cancers. 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 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.
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.
You can have more than one problem 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 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 or persistent muscle pain, 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,
diarrhea, muscle or bone pain, and nausea. 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 accompanying full Prescribing Information,
including Medication Guide.
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 over 30 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to eight 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, pain, 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 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
Regeneron's product candidates and research and clinical programs
now underway or planned, including without limitation
Libtayo® (cemiplimab) for the treatment of patients with
first-line locally advanced or metastatic non-small cell lung
cancer (NSCLC) with ≥50% PD-L1 expression; 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 the treatment of NSCLC, basal cell carcinoma,
adjuvant and neoadjuvant cutaneous squamous cell carcinoma,
cervical cancer, and other potential indications;
uncertainty of market acceptance and commercial success of
Regeneron's Products and product candidates and the impact of
studies (whether conducted by Regeneron or others and whether
mandated or voluntary) on the commercial success of Regeneron's
Products (including without limitation Libtayo) and product
candidates; safety issues resulting from the administration of
Regeneron's Products (such as Libtayo) and product candidates in
patients, including serious complications or side effects in
connection with the use of Regeneron's Products and 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 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 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 product candidates; the extent to which
the results from the research and development programs conducted by
Regeneron and/or its collaborators may be replicated in other
studies and/or lead to advancement of product candidates to
clinical trials, therapeutic applications, or regulatory approval;
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; 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; 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), and
Praluent® (alirocumab)), 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, 2019 and its Form 10-Q
for the quarterly period ended June
30, 2020. 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).
Regeneron Contacts:|
Media Relations
Daren
Kwok
Tel: +1 (914) 847-1328
daren.kwok@regeneron.com
Investor Relations
Vesna
Tosic
Tel: +1 (914) 847-5443
vesna.tosic@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.