Sarclisa approved in Japan for patients with
newly diagnosed multiple myeloma
- Approval offers access to new
treatment options for newly diagnosed MM patients
- Approval based on positive results
from the IMROZ phase 3 study that demonstrated Sarclisa in
combination with VRd significantly improved progression-free
survival, compared to VRd alone in transplant-ineligible newly
diagnosed multiple myeloma
Paris, February 25, 2025. The
Ministry of Health, Labour and Welfare (MHLW) in Japan has approved
Sarclisa, in combination with bortezomib, lenalidomide, and
dexamethasone (VRd), for the treatment of adult patients with newly
diagnosed multiple myeloma (NDMM) based on data from the IMROZ
phase 3 study.
Olivier NatafGlobal Head,
Oncology“In recent years, new multiple myeloma cases have increased
steadily in Japan and other Asian-Pacific nations, creating a need
for new treatment approaches, particularly in the front-line
setting. While Sarclisa-based combinations have been approved for
relapsed or refractory patients in Japan, this approval represents
the first indication for certain newly diagnosed patients. We are
pleased to offer physicians an important new option for their
patients earlier in the treatment journey, building upon our
continued commitment to advancing innovative oncology treatments in
difficult-to-treat hematologic malignancies around the world.”
In Japan, Sarclisa was launched in August 2020
and has been approved for four different treatment regimens (in
combination with pomalidomide and dexamethasone, as monotherapy, in
combination with carfilzomib and dexamethasone, or in combination
with dexamethasone for the treatment of patients with relapsed or
refractory multiple myeloma). In addition, Sarclisa has front-line
approvals in the EU and the US. In the Asia Pacific region,
Sarclisa combination regimens were also recently approved by the
National Medical Products Administration in China, specifically
Sarclisa-VRd in NDMM patients who are not eligible for autologous
stem cell transplant, as well as Sarclisa in combination with
pomalidomide and dexamethasone (Pd) for the treatment of adult
patients with relapsed or refractory MM who have received at least
one prior line of therapy, including lenalidomide and a proteasome
inhibitor.
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 Food and Drug Administration.
Currently, Sarclisa is approved in more than 50
countries, including in the US, EU, Japan, and China, across
multiple indications. Based on the ICARIA-MM phase 3 study,
Sarclisa is approved in the US, EU and Japan in combination with Pd
for the treatment of patients with R/R MM who have received ≥two
prior therapies, including lenalidomide and a proteasome inhibitor;
this combination is also approved in China for patients who have
received at least one prior line of therapy, including lenalidomide
and a proteasome inhibitor. Based on the IKEMA phase 3 study,
Sarclisa is also approved in more than 50 countries in combination
with carfilzomib and dexamethasone, including in the US for the
treatment of patients with R/R MM who have received one to three
prior lines of therapy and in the EU for patients with MM who have
received at least one prior therapy. In the US, EU, UK, and China,
Sarclisa is approved in combination with VRd as a front-line
treatment option in transplant-ineligible NDMM patients, based on
the IMROZ phase 3 study. This combination is also approved in Japan
for patients with NDMM.
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 (SC) administration method for
Sarclisa in clinical studies. In January 2024, Sanofi reported
positive results from the IRAKLIA phase 3 study evaluating Sarclisa
SC formulation administered via an on-body delivery system (OBDS)
in combination with Pd compared to intravenous (IV) Sarclisa in
patients with R/R MM. In December 2024, additional positive results
from the program, including the GMMG-HD7 phase 3 study evaluating
Sarclisa-RVd induction therapy in transplant-eligible NDMM
patients, were also presented at the 66th American Society of
Hematology Annual Meeting and Exposition. 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 gastroenteropancreatic
neuroendocrine tumors and other 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
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