Sarclisa approved in the EU as the first
anti-CD38 therapy in combination with standard-of-care VRd to treat
transplant-ineligible newly diagnosed multiple myeloma
- Approval is based on positive
results from the IMROZ phase 3 study, demonstrating Sarclisa in
combination with standard-of-care treatment significantly improved
PFS, compared to the standard of care alone in TI NDMM
- Represents third indication in the
EU, including two for the treatment of adult patients with R/R MM,
and one in NDMM
Paris, January 22, 2025.
Following the adoption of a positive opinion by the European
Medicines Agency’s (EMA) Committee for Medicinal Products for Human
Use (CHMP), the EU has approved Sarclisa in combination with a
standard-of-care regimen, bortezomib, lenalidomide, and
dexamethasone (VRd), for the treatment of adult patients with newly
diagnosed multiple myeloma (NDMM) ineligible for autologous stem
cell transplant (ASCT), based on data from the IMROZ phase 3 study.
With the expanded marketing authorization, Sarclisa is the first
anti-CD38 therapy in combination with VRd in this patient
population in the EU.
Olivier NatafGlobal Head of
Oncology at Sanofi“While there have been many important
advancements in multiple myeloma treatment over the past decade,
there remains a significant unmet need in the front-line setting,
particularly for transplant-ineligible patients. With today’s
decision the 27 countries in the EU will have access to a
potentially transformative new combination regimen, marking a
significant step forward in our mission to make a meaningful
difference in multiple myeloma treatment.”
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
front-line setting. In addition, the FDA granted orphan drug
exclusivity for Sarclisa in the approved indication. Beyond the US
and the EU, regulatory submissions for Sarclisa in NDMM not
eligible for ASCT are under review in Japan and in China.
About SarclisaSarclisa (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 in the EU, across three
indications. Based on the ICARIA-MM phase 3 study, Sarclisa is
approved in combination with pomalidomide and dexamethasone (Pd)
for the treatment of patients with relapsed or refractory MM (R/R
MM) 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 R/R MM who
have received 1–3 prior lines of therapy and in the EU for patients
with MM who have received at least 1 prior therapy. In the US and
EU, Sarclisa is approved in combination with VRd as a front-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 often rare 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
Media RelationsSandrine
Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.com Evan Berland |
+1 215 432 0234 | evan.berland@sanofi.com Nicolas
Obrist | + 33 6 77 21 27 55 |
nicolas.obrist@sanofi.com Léo Le Bourhis | + 33 6
75 06 43 81 | leo.lebourhis@sanofi.com Victor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.comTimothy
Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.com
Investor RelationsThomas Kudsk
Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 |
alize.kaisserian@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.com Keita
Browne | + 1 781 249 1766 |
keita.browne@sanofi.comNathalie Pham | +
33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik
Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 |
thibaud.chatelet@sanofi.com
Sanofi forward-looking
statementsThis press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These statements include projections
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Forward-looking statements are generally identified by the words
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things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
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competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, and the
impact that pandemics or other global crises may have on us, our
customers, suppliers, vendors, and other business partners, and the
financial condition of any one of them, as well as on our employees
and on the global economy as a whole. The risks and uncertainties
also include the uncertainties discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under “Risk Factors” and “Cautionary Statement
Regarding Forward-Looking Statements” in Sanofi’s annual report on
Form 20-F for the year ended December 31, 2023. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
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