European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), the EU has approved Sarclisa in combination with a standard-of-care regimen—bortezomib, lenalidomide, and dexamethasone (VRd)—for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT). This approval is based on data from the IMROZ phase 3 study, making Sarclisa the first anti-CD38 therapy in combination with VRd for this patient population in the EU.
A Breakthrough for Transplant-Ineligible NDMM Patients
The approval of Sarclisa marks a significant advancement for NDMM patients who are not candidates for autologous stem cell transplants. Multiple myeloma is a challenging and complex cancer of the plasma cells, and treatment options for transplant-ineligible patients have historically been limited. Sarclisa’s approval offers new hope for improved outcomes in this patient group.
Olivier Nataf, Global Head of Oncology at Sanofi, highlighted the importance of this development: “While there have been many important advancements in multiple myeloma treatment over the past decade, there remains a significant unmet need in the front-line setting, particularly for transplant-ineligible patients. With today’s decision, the 27 countries in the EU will have access to a potentially transformative new combination regimen, marking a significant step forward in our mission to make a meaningful difference in multiple myeloma treatment.”
The IMROZ Phase 3 Study: Evidence Supporting It’s Approval
The EU’s decision to approve Sarclisa was heavily influenced by the results of the IMROZ phase 3 clinical trial. This study evaluated the safety and efficacy of Sarclisa in combination with VRd in transplant-ineligible NDMM patients. The trial demonstrated significant benefits, including improved progression-free survival (PFS) and a manageable safety profile, underscoring Sarclisa’s potential to redefine the standard of care for this population.
Key findings from the IMROZ study include:
- Enhanced Efficacy: Patients receiving Sarclisa combined with VRd exhibited significantly longer PFS compared to those receiving VRd alone.
- Safety Profile: The combination regimen showed a manageable safety profile, with no unexpected adverse events, aligning with Sarclisa’s established safety data.
These results solidify Sarclisa’s role as a groundbreaking addition to the treatment landscape for NDMM patients who are ineligible for transplant.
Addressing Unmet Needs in Multiple Myeloma
Multiple myeloma remains a challenging disease to treat, particularly in the front-line setting. While significant progress has been made in the development of therapies, patients who are not eligible for transplants often face limited options. Sarclisa’s approval addresses this critical gap, offering a novel therapeutic option designed to improve outcomes and enhance quality of life for patients.
Global Momentum: Sarclisa’s Expansion Beyond the EU
Sarclisa’s approval in the EU follows its initial regulatory success in the United States. 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. This milestone represented the first global approval for Sarclisa in the front-line setting and established its position as a transformative therapy for NDMM patients.
Additionally, the FDA granted orphan drug exclusivity for It in this indication, underscoring its potential to address an area of significant unmet medical need.
Beyond the US and the EU, regulatory submissions for Sarclisa in NDMM not eligible for ASCT are currently under review in Japan and China. If approved, these markets will further expand access to Sarclisa, enabling more patients worldwide to benefit from this innovative therapy.
What Sets It Apart?
Sarclisa (isatuximab-irfc) is a monoclonal antibody that targets CD38, a protein highly expressed on the surface of multiple myeloma cells. By binding to CD38, Sarclisa triggers immune-mediated mechanisms that lead to the destruction of cancerous plasma cells. This mechanism of action, combined with its efficacy and safety profile, makes Sarclisa a valuable addition to the therapeutic arsenal against multiple myeloma.
The combination of It with VRd represents a paradigm shift in the treatment of NDMM, particularly for patients who are ineligible for ASCT. By integrating this therapy into the front-line setting, clinicians can offer patients a more effective and comprehensive approach to managing their disease.
The Broader Impact of Its Approval
It’s approval in the EU is a testament to Sanofi’s commitment to advancing oncology research and addressing the needs of underserved patient populations. By prioritizing innovative therapies and investing in rigorous clinical trials, Sanofi has established itself as a leader in the fight against multiple myeloma.
This approval also highlights the collaborative efforts of regulatory agencies, healthcare providers, and pharmaceutical companies to bring cutting-edge treatments to patients. By working together, these stakeholders can accelerate the development and availability of life-changing therapies, ultimately improving outcomes for patients worldwide.
A New Era in Multiple Myeloma Treatment
The approval of It in combination with VRd for transplant-ineligible NDMM patients marks a new era in the treatment of multiple myeloma. By offering a novel therapeutic option that addresses a critical unmet need, Sarclisa has the potential to transform the standard of care and significantly improve patient outcomes.
As regulatory submissions continue to progress in other regions, the global impact of It is expected to grow. For patients and healthcare providers alike, this approval represents a beacon of hope and a reminder of the power of innovation in the fight against cancer.
Read more: Sarclisa Approved in EU for Treating Transplant-Ineligible Newly Diagnosed Multiple Myeloma
