Sarclisa Recommended for EU Approval by the CHMP to Treat Transplant-Ineligible Newly Diagnosed Multiple Myeloma
Positive Recommendation for Sarclisa
Paris, November 14, 2024. The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT).
IMROZ Phase 3 Study Results
The recommendation is based on the results of the IMROZ phase 3 study, which demonstrated that Sarclisa in combination with VRd significantly improved progression-free survival compared to the standard-of-care VRd alone. If approved, Sarclisa would be the first anti-CD38 therapy in the EU available for use in combination with VRd for adult patients with transplant-ineligible NDMM.
Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow. It is the second most common hematological cancer, with approximately 40,000 new cases diagnosed in Europe each year. Treatment options for multiple myeloma have evolved significantly in recent years, with new therapies offering improved outcomes for patients.
Sarclisa is a monoclonal antibody that targets CD38, a protein that is highly expressed on the surface of myeloma cells. By targeting CD38, Sarclisa helps to kill cancer cells and reduce the growth of tumors. The combination of Sarclisa with VRd has shown promising results in clinical trials, with a significant improvement in progression-free survival compared to VRd alone.
Impact on Patients
For patients with transplant-ineligible newly diagnosed multiple myeloma, the potential approval of Sarclisa in combination with VRd represents a new treatment option that could offer improved outcomes and a better quality of life. By targeting CD38, Sarclisa offers a targeted approach to treating myeloma, which may result in fewer side effects and a better response to treatment.
Impact on the World
The approval of Sarclisa in the EU would be a significant advancement in the treatment of multiple myeloma, offering a new therapy option for patients who are ineligible for stem cell transplant. Sarclisa’s approval in combination with VRd would pave the way for other anti-CD38 therapies to be used in similar treatment regimens, potentially improving outcomes for patients with myeloma worldwide.
Conclusion
The positive recommendation for Sarclisa by the CHMP is a significant step forward in the treatment of transplant-ineligible newly diagnosed multiple myeloma. If approved, Sarclisa in combination with VRd has the potential to improve outcomes for patients and pave the way for new treatment options in the future.
