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 LibtayoLibtayo 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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