Sanofi’s Sarclisa Becomes First Anti-CD38 Therapy Approved in the EU for Front-Line Treatment of Transplant-Ineligible Multiple Myeloma

(IN BRIEF) Sanofi’s Sarclisa has been approved by the European Union as the first anti-CD38 therapy in combination with VRd to treat adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. This approval is based on positive results from the IMROZ phase 3 study and follows Sarclisa’s recent FDA approval for the same indication. With this expansion, Sarclisa strengthens its position in the treatment of multiple myeloma across multiple global markets.

(PRESS RELEASE) PARIS, 22-Jan-2025 — /EuropaWire/ — Sanofi’s Sarclisa (isatuximab) has received European Union approval as the first anti-CD38 therapy in combination with the standard-of-care regimen VRd (bortezomib, lenalidomide, and dexamethasone) to treat adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). This approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), based on data from the IMROZ phase 3 study. Sarclisa is now the first therapy in its class to be combined with VRd for this patient population in the EU.

The approval marks a significant step forward for Sarclisa, as it expands its reach in treating multiple myeloma, a cancer with complex and evolving treatment needs. Olivier Nataf, Global Head of Oncology at Sanofi, highlighted the importance of this milestone, stating, “While there have been many advancements in the treatment of multiple myeloma, the unmet need for transplant-ineligible patients remains significant. This approval provides access to a potentially transformative combination therapy for patients across the 27 EU countries and represents a meaningful leap forward in our efforts to revolutionize the treatment landscape for multiple myeloma.”

Sarclisa’s approval in the EU follows its recent FDA approval in September 2024 for the same indication, marking its global debut in the front-line treatment setting for NDMM patients who are not eligible for ASCT. The US approval also includes orphan drug exclusivity. Regulatory submissions for Sarclisa in this indication are currently under review in both Japan and China.

Sarclisa is a CD38 monoclonal antibody designed to target and bind to the CD38 receptor on multiple myeloma cells, inducing antitumor activity through several mechanisms, including programmed tumor cell death (apoptosis) and immunomodulatory effects. CD38’s high and consistent expression on myeloma cells makes it a valuable target for therapies like Sarclisa.

Currently, Sarclisa is approved in over 50 countries, including the US and the EU, across three indications. It is already approved in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (R/R MM) who have undergone at least two prior therapies, including lenalidomide and a proteasome inhibitor. Sarclisa is also approved in combination with carfilzomib and dexamethasone for R/R MM patients who have received 1-3 prior therapies.

Sanofi is committed to advancing Sarclisa’s clinical development with an ongoing patient-centric program that spans multiple phase 2 and phase 3 studies, targeting various stages of multiple myeloma and potential new indications. The company is also exploring the possibility of a subcutaneous administration method for Sarclisa in clinical trials.

Sanofi’s dedication to oncology innovation remains a cornerstone of its mission to become the global leader in immunoscience. The company is focusing on hard-to-treat cancers with significant unmet needs, including hematologic malignancies like multiple myeloma, acute myeloid leukemia, and select lymphomas, as well as solid tumors such as gastrointestinal and lung cancers.

For more information about Sarclisa’s clinical studies, visit www.clinicaltrials.gov.

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 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

Sanofi forward-looking statements
This 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 and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other 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 marketing, unexpected safety, quality or manufacturing issues, 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.

Sanofi’s Sarclisa Becomes First Anti-CD38 Therapy Approved in the EU for Front-Line Treatment of Transplant-Ineligible Multiple Myeloma

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