Sarclisa Approved in US for Newly Diagnosed Multiple Myeloma Patients Not Eligible for Transplant

The US Food and Drug Administration (FDA) has granted approval for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT). This approval makes Sarclisa the first anti-CD38 therapy to be combined with standard-of-care VRd, demonstrating a significant 40% reduction in disease progression or death compared to VRd alone in this patient group.

Dr. Thomas Martin from the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, emphasized the importance of this approval. He highlighted that multiple myeloma is often diagnosed in patients aged 65 and older, a demographic with limited treatment options due to age-related factors and co-morbidities. The approval of Sarclisa, therefore, addresses a critical need for new treatments that can improve the standard-of-care and offer significant clinical benefits.

The FDA’s decision, evaluated under Priority Review, marks the third approved indication for Sarclisa in the US and its first approval for newly diagnosed patients. Brian Foard, Executive Vice President and Head of Specialty Care at Sanofi, noted that this approval is a significant milestone for Sarclisa, expanding its reach to a larger population and providing a new therapeutic option that slows disease progression more effectively than the current standard-of-care.

The approval is based on data from the IMROZ phase 3 study, recently presented at the American Society of Clinical Oncology (ASCO) 2024 annual meeting and published in The New England Journal of Medicine. IMROZ is the first global phase 3 study to show that an anti-CD38 monoclonal antibody combined with VRd significantly improves progression-free survival (PFS) compared to VRd alone. In this study, the Sarclisa-VRd combination followed by Sarclisa-Rd met the primary endpoint of PFS, reducing the risk of recurrence or death by 40%. At a median follow-up of 59.7 months, the median PFS with the Sarclisa-VRd combination was not reached, versus 54.3 months for VRd.

Secondary endpoints of the study showed that 74.7% of patients treated with Sarclisa-VRd achieved a complete response or better, compared to 64.1% with VRd. Additionally, 55.5% of patients in the Sarclisa-VRd group achieved minimal residual disease (MRD) negative complete response, compared to 40.9% in the VRd group. The safety profile of Sarclisa in this combination was consistent with previous studies, with the most common adverse reactions including upper respiratory tract infections, diarrhea, and fatigue.

Sanofi continues to advance Sarclisa through a patient-centric clinical development program, with several phase 2 and phase 3 studies investigating its efficacy across different stages of multiple myeloma treatment. The company is also exploring a subcutaneous administration method for Sarclisa.

Sarclisa is a monoclonal antibody targeting the CD38 receptor on multiple myeloma cells, inducing tumor cell death and immunomodulatory activity. Currently, Sarclisa is approved in combination with other treatments for relapsed or refractory multiple myeloma (RRMM) in over 50 countries. Sanofi remains committed to expanding the use of Sarclisa through ongoing clinical trials and innovative treatment strategies, aiming to improve outcomes for patients with multiple myeloma.