Source: Sanofi (EURONEXT: SAN) (NYSE: SNY)
* CSCC is the second most common skin cancer in
Canadai
TORONTO, April 11, 2019 /CNW Telbec/ - Sanofi
Genzyme, the Specialty Care Business Unit of sanofi-aventis Canda
Inc, announced today that Health Canada has issued a Notice of
Compliance with conditions (NOC/c) for LibtayoTM
(cemiplimab) for the treatment of adult patients with metastatic or
locally advanced cutaneous squamous cell carcinoma (CSCC) who are
not candidates for curative surgery or curative radiation. The
market authorization is conditional pending the results of studies
to verify its clinical benefit. LibtayoTM is a
fully-human monoclonal antibody targeting the immune checkpoint
receptor PD-1 (programmed cell death protein-1) and is the first
and only biologic treatment specifically approved and available for
advanced CSCC in Canada.
"Today's Health Canada decision
is great news for patients with advanced CSCC, who previously had
no approved treatment options," says Dr. Joel Claveau, M.D., dermatologist specialized in
the diagnosis and treatment of melanoma and skin cancers, and
Associate Professor with the Department of Medicine at Le
Centre Hospitalier Universitaire de Québec, Hôpital Hôtel-Dieu,
Quebec City.
"Libtayo is an important new immunotherapy option
for Canadian physicians to help address a significant unmet need in
this patient group."
CSCC is the second most common form of skin cancer accounting
for approximately one-fifth of all skin cancer cases in
Canadaii. When CSCC
invades deeper layers of the skin or adjacent tissues, it is
categorized as locally advanced. Once it spreads to other distant
parts of the body, it is considered metastatic.iii
"Canadians living with
metastatic cutaneous squamous cell carcinoma are in urgent need of
access to new therapeutic options to treat this elusive yet serious
skin cancer, especially in the case of advanced disease," says
Kathy Barnard, Founder of Save Your
Skin Foundation. "We applaud Health Canada's approval
of Libtayo, which provides new hope for patients and their loved
ones."
Annette Cyr, Chair of the
Melanoma Network of Canada,
agrees:
"Patients with advanced
metastatic CSCC face significant life threatening challenges, not
to mention the physical and emotional impacts of this disease.
Beyond surgery and radiation, there hasn't been many options," she
says. "Today's approval of Libtayo by Health Canada provides a
treatment option that gives our patient community and their
families reason to hope."
Prior to today's announcement, in 2018
LibtayoTM(cemiplimab-rwlc) received FDA approval under
Priority Review and was granted Breakthrough Therapy Designation
status for the treatment of patients with metastatic CSCC or
locally advanced CSCC who are not candidates for curative surgery
or curative radiation.Breakthrough Therapy Designation was created
to expedite the development and review of drugs that have the
potential for substantial improvement in the treatment of serious
or life-threatening conditions.
"The approval of Libtayo
represents Sanofi Genzyme's commitment to the CSCC community, who
have been suffering the burden of their condition," states
Marissa Poole, General Manager,
Sanofi Genzyme Canada. "This treatment provides hope for Canadian
patients living with advanced CSCC as the first approved biologic
treatment to address the debilitating impact of this devastating
disease and fills a critical treatment gap."
About LibtayoTM
LibtayoTM 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.
LibtayoTM is manufactured by Regeneron, and jointly
developed and commercialized globally by Regeneron and Sanofi.
The Health Canada Notice of Compliance with conditions (NOC/c)
of LibtayoTM was based on a combined analysis of
data from an open-label, multi-center, non-randomized Phase 2 trial
known as EMPOWER-CSCC-1 (Study 1540) and two advanced CSCC
expansion cohorts from a multi-center, open-label, non-randomized
Phase 1 trial (Study 1423). Together, the trials represent the
largest prospective data set in advanced CSCC.
About Cutaneous Squamous Cell Carcinoma (CSCC)
CSCC
starts in squamous cells of the skin, which are flat cells found in
the outer part of the epidermis.
When CSCC is found very early and only in the epidermis, it is
called CSCC in situ. It isn't usually life-threatening because it
is an early form of CSCC. CSCC in situ may turn into invasive CSCC
if not treated. This means that the cancer can grow into nearby
tissue or deeper layers of skin.
The leading cause of CSCC is frequent sun exposure. People with
fair skin, light hair, and blue, green, or gray eyes are at the
highest risk.iv
The symptoms of CSCC include:
- Warts that grow and crust or bleed occasionally.
- Scaly red patches, with irregular borders, which sometimes
crust or bleed.
- Sores that are open, and bleed and crust for weeks.
- An elevated growth with a central dip that occasionally
bleeds.
If lesions are untreated, they may continue to grow, causing
damage to the surrounding tissue. This damage could cause the
lesion to spread to other parts of the body.v
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.
In Canada, we employ close to
2,000 people. In 2017, Sanofi companies invested $123 million in R&D in Canada, creating jobs, business and
opportunity throughout the country.
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families. To learn more
about our company, visit www.sanofi.ca or follow us on Twitter
@SanofiCanada.
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i
|
Melanoma Network of
Canada, Non-melanoma Skin Cancer.
https://www.melanomanetwork.ca/skincancer/
|
ii
|
Canadian Cancer
Society, Types of non-melanoma skin
cancer. http://www.cancer.ca/en/cancer-information/cancer-type/skin-non-melanoma/non-melanoma-skin-cancer/types-of-non-melanoma/?region=on
|
iii
|
Skin Cancer
Foundation, Treatment Options,
https://www.skincancer.org/skin-cancer-information/squamous-cell-carcinoma/scc-treatment-options
|
iv
|
Canadian Cancer
Society, Types of non-melanoma skin cancer.
http://www.cancer.ca/en/cancer-information/cancer-type/skin-non-melanoma/non-melanoma-skin-cancer/types-of-non-melanoma/?region=on
|
v
|
Melanoma Network of
Canada, Non-melanoma Skin Cancer.
https://www.melanomanetwork.ca/skincancer/
|
SOURCE Sanofi-Aventis Canada Inc.