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 decisionThe
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 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 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 SanofiWe 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.comEvan Berland |
+1 215 432 0234 | evan.berland@sanofi.comNicolas
Obrist | + 33 6 77 21 27 55 |
nicolas.obrist@sanofi.comVictor
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.comAlizé
Kaisserian | + 33 6 47 04 12 11 |
alize.kaisserian@sanofi.comArnaud
Delépine | + 33 6 73 69 36 93 |
arnaud.delepine@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comKeita
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.comThibaud Châtelet | + 33 6
80 80 89 90 | thibaud.chatelet@sanofi.com
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