CHMP issues positive opinion for Libtayo®
(cemiplimab) in advanced cutaneous squamous cell
carcinoma
- Currently no approved treatments in the European
Union for advanced cutaneous squamous cell carcinoma (CSCC)
- CSCC is one of the most common skin cancers
worldwide[i]
PARIS and TARRYTOWN, NY - April 26, 2019 - The
European Medicines Agency's (EMA) Committee for Medicinal Products
for Human Use (CHMP) has adopted a positive opinion for the
marketing authorization of Libtayo® (cemiplimab).
The CHMP recommended its conditional approval 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.
Libtayo is a fully-human monoclonal antibody targeting the immune
checkpoint receptor PD-1 (programmed cell death protein-1). If
approved, Libtayo would be the first and only treatment approved
for certain patients with advanced CSCC in the European Union
(EU).
CSCC is one of the most commonly diagnosed skin cancers
worldwide.i In Europe,
CSCC occurs twice as often as melanoma, and its incidence is
estimated to be increasing substantially in some
countries.i[ii][iii]-[iv] Although
the majority of patients with CSCC have a good prognosis when the
cancer is found early, the cancer can be especially difficult to
treat when it progresses to advanced stages.i,v-[v],
[vi],
[vii],
[viii] Advanced
CSCC includes both patients with locally advanced disease (where
the cancer invades deeper layers of the skin or spreads nearby) and
patients with metastatic disease (when the cancer spreads to other
parts of the body).
The CHMP opinion is based on data from the pivotal, open-label,
multi-center, non-randomized Phase 2 EMPOWER-CSCC-1 trial (Study
1540) and supported by two advanced CSCC expansion cohorts from a
multi-center, open-label, non-randomized Phase 1 trial. Together,
the trials represent the largest prospective dataset of advanced
CSCC patients.
As part of the conditional approval, Sanofi and Regeneron will need
to provide additional data from EMPOWER-CSCC-1, including results
from a newly added group to the trial, to further confirm the
benefit-risk profile of Libtayo. The European Commission is
expected to make a final decision on the application for Libtayo in
the coming months.
Libtayo is being jointly developed by Sanofi and Regeneron under a
global collaboration agreement.
About Libtayo Libtayo is
approved in the U.S. for the treatment of patients with metastatic
CSCC or locally advanced CSCC who are not candidates for curative
surgery or curative radiation, and in other countries for similar
indications.[ix],[x] 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.
Libtayo is also being investigated in potential registrational
trials in non-small cell lung cancer, basal cell carcinoma and
cervical cancer, along with additional 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.
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.
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