Press Release: Sarclisa recommended for EU approval by the CHMP to
treat transplant-ineligible newly diagnosed multiple myeloma
Sarclisa recommended for EU approval by the
CHMP to treat transplant-ineligible newly diagnosed multiple
myeloma
- Recommendation based on IMROZ phase
3 study demonstrating Sarclisa in combination with VRd
significantly improved progression-free survival, compared to
standard-of-care VRd alone
- If approved, Sarclisa would be the
first anti-CD38 therapy in the EU available for use in combination
with VRd for adult patients with transplant-ineligible NDMM
Paris, November 14, 2024. The European Medicines
Agency (EMA)’s Committee for Medicinal Products for Human Use
(CHMP) has adopted a positive opinion recommending the approval of
Sarclisa in combination with bortezomib, lenalidomide, and
dexamethasone (VRd) for the treatment of adult patients with newly
diagnosed multiple myeloma (NDMM) who are ineligible for autologous
stem cell transplant (ASCT). A final decision is expected in the
coming months.
Dietmar Berger, M.D.,
Ph.D.
Chief Medical Officer, Global Head of Development at Sanofi
“The positive CHMP opinion is an important step forward for
people with transplant-ineligible newly diagnosed multiple myeloma
for whom effective front-line therapy may improve long-term
outcomes. If approved, this Sarclisa-based combination could
establish a new standard-of-care treatment approach for patients in
the EU, helping to address a critical care gap in multiple myeloma
treatment, and reinforcing Sarclisa’s potential as the anti-CD38
therapy of choice.”
In September 2024, the US Food and Drug
Administration (FDA) approved Sarclisa in combination with VRd for
the treatment of adult patients with NDMM who are not eligible for
ASCT, representing the first global approval for Sarclisa in the
first line setting. In addition, the FDA granted orphan drug
exclusivity for Sarclisa in the approved indication.
Sarclisa is currently approved in two
indications for the treatment of certain adult patients with
relapsed or refractory MM in more than 50 countries, including the
US and EU.
First positive global phase 3 study
combining anti-CD38 therapy with VRd to significantly improve PFS
versus VRd alone in transplant-ineligible NDMM supports CHMP
decision
The positive CHMP opinion is based on data from the IMROZ phase 3
study, which was presented at the American Society of Clinical
Oncology 2024 annual meeting, European Hematology Association 2024
meeting, and published in The New England Journal of
Medicine. IMROZ is the first global phase 3 study of a CD38
monoclonal antibody in combination with standard-of-care VRd to
significantly improve progression-free survival (PFS) versus VRd
alone. The safety and tolerability of Sarclisa observed was
consistent with the established safety profile of Sarclisa and VRd
with no new safety signals.
About Sarclisa
Sarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a
specific epitope on the CD38 receptor on MM cells, inducing
distinct antitumor activity. It is designed to work through
multiple mechanisms of action including programmed tumor cell death
(apoptosis) and immunomodulatory activity. CD38 is highly and
uniformly expressed on the surface of MM cells, making it a target
for antibody-based therapeutics such as Sarclisa. In the US, the
non-proprietary name for Sarclisa is isatuximab-irfc, with irfc as
the suffix designated in accordance with nonproprietary naming of
biological products guidance for industry issued by the US FDA.
Currently Sarclisa is approved in more than 50
countries, including the US and EU, across two indications;
Sarclisa is approved under an additional indication in the US. In
Europe, based on the ICARIA-MM phase 3 study, Sarclisa is approved
in combination with pomalidomide and dexamethasone for the
treatment of patients with relapsed refractory MM (RRMM) who have
received ≥2 prior therapies, including lenalidomide and a
proteasome inhibitor and who progressed on last therapy. Based on
the IKEMA phase 3 study, Sarclisa is also approved in 50 countries
in combination with carfilzomib and dexamethasone, including in the
US for the treatment of patients with RRMM who have received 1–3
prior lines of therapy and in the European Union for patients with
MM who have received at least 1 prior therapy. In the US, Sarclisa
is also approved in combination with VRd as a first line treatment
option for adult patients with NDMM who are not eligible for ASCT,
based on the IMROZ phase 3 study.
Sanofi continues to advance Sarclisa as part of
a patient-centric clinical development program, which includes
several phase 2 and phase 3 studies across the MM treatment
continuum spanning six potential indications. In addition, the
company is evaluating a subcutaneous administration method for
Sarclisa in clinical studies. The safety and efficacy of Sarclisa
has not been evaluated by any regulatory authority outside of its
approved indications and methods of delivery.
In striving to become the number one
immunoscience company globally, Sanofi remains committed to
advancing oncology innovation. Through focused strategic decisions
the company has reshaped and prioritized its pipeline, leveraging
its expertise in immunoscience to drive progress. Efforts are
centered on difficult-to-treat cancers such as select hematologic
malignancies and solid tumors with critical unmet needs, including
multiple myeloma, acute myeloid leukemia, certain types of
lymphomas, as well as gastrointestinal and lung cancers.
For more information on Sarclisa clinical
studies, please visit www.clinicaltrials.gov.
About Sanofi
We are an innovative global healthcare company, driven by one
purpose: we chase the miracles of science to improve people’s
lives. Our team, across the world, is dedicated to transforming the
practice of medicine by working to turn the impossible into the
possible. We provide potentially life-changing treatment options
and life-saving vaccine protection to millions of people globally,
while putting sustainability and social responsibility at the
center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY
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