Sanofi’s Sarclisa Receives Approval in China for Newly Diagnosed Multiple Myeloma Treatment

Sanofi’s Sarclisa Receives Approval in China for Newly Diagnosed Multiple Myeloma Treatment

(IN BRIEF) Sarclisa (isatuximab) has been approved in China for use in combination with the VRd regimen to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant. The approval is based on positive results from the IMROZ phase 3 study. This is the second approval in China within three weeks, following the approval for relapsed or refractory multiple myeloma. Sarclisa is already approved in over 50 countries for various indications and continues to be a key part of Sanofi’s ongoing efforts to advance treatments for multiple myeloma globally.

(PRESS RELEASE) PARIS, 1-Feb-2025 — /EuropaWire/ — The National Medical Products Administration (NMPA) in China has granted approval for Sarclisa (isatuximab) in combination with the standard-of-care regimen VRd (bortezomib, lenalidomide, and dexamethasone) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). This marks a significant milestone in the expansion of Sarclisa’s role in treating multiple myeloma in China.

The approval follows the promising results of the IMROZ phase 3 study, which demonstrated that Sarclisa in combination with VRd significantly improves progression-free survival in transplant-ineligible newly diagnosed multiple myeloma patients compared to VRd alone. This represents Sarclisa’s second approval in China in just three weeks, following its initial approval in January 2025 for relapsed or refractory multiple myeloma (R/R MM).

Advancing Treatment Access in China and Beyond

Olivier Nataf, Global Head of Oncology at Sanofi, expressed the significance of this approval: “This decision represents a major step forward for our mission to bring transformative therapies to Chinese patients. Sarclisa’s approval now provides patients with access to not one, but two new treatment regimens, offering new hope for better clinical outcomes.”

Following closely on the heels of the R/R MM approval, Sarclisa’s approval in the newly diagnosed, transplant-ineligible setting in China further expands the drug’s reach. The positive impact of these treatments aligns with Sanofi’s commitment to improving patient outcomes in the global fight against multiple myeloma, particularly in emerging markets such as China.

A Global Expansion and Ongoing Clinical Development

Sarclisa has received approval in more than 50 countries, including the US, EU, Japan, and China, for multiple indications in combination with other therapies. With approvals based on studies like ICARIA-MM and IKEMA, Sarclisa is already a trusted option for patients with relapsed and refractory multiple myeloma (R/R MM). Furthermore, Sarclisa is also approved for use in combination with VRd in transplant-ineligible NDMM patients in the US, EU, and China, based on the IMROZ study.

Sanofi continues to push the boundaries of cancer care, with Sarclisa being evaluated in a variety of ongoing clinical trials. In particular, the company is working towards the introduction of a subcutaneous (SC) formulation, which aims to improve patient convenience and treatment adherence. The promising data from studies like the IRAKLIA phase 3 and GMMG-HD7 phase 3 trials continue to drive optimism about Sarclisa’s future impact on multiple myeloma treatment.

Looking Ahead

Sanofi’s focus remains on the development of therapies for hematologic malignancies and cancers with high unmet needs, including acute myeloid leukemia, lymphomas, and gastrointestinal cancers. Sarclisa’s growing list of approved indications reflects the company’s dedication to oncology innovation and the ongoing advancement of treatments that improve survival rates and quality of life for patients worldwide.

For more information on Sarclisa’s ongoing 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 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, 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.

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

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SOURCE: Sanofi group