CHMP Recommends Sarclisa for New Multiple Myeloma Use

Sanofi's Sarclisa (isatuximab) has gained pivotal support from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), which has recommended the drug for approval as part of a combination treatment for newly diagnosed multiple myeloma (MM). Specifically, Sarclisa is advised to be used alongside bortezomib, lenalidomide, and dexamethasone (known as VRd) as an induction therapy for adults diagnosed with MM who qualify for autologous stem cell transplant.

The endorsement is founded on promising outcomes from the first part of the phase 3 German-speaking Myeloma Multicenter Group (GMMG)-HD7 study. This research demonstrated that the inclusion of Sarclisa in VRd induction therapy significantly boosts the benefits of minimal residual disease negativity and extends progression-free survival compared to the use of VRd alone. The second phase of the study involves patients being re-randomized to receive Sarclisa with lenalidomide versus lenalidomide alone as a maintenance treatment after the transplant.

Multiple myeloma stands as the second most prevalent blood cancer, following non-Hodgkin lymphoma, with an estimated 46,000 new cases expected to be identified in Europe this year. Sarclisa is already sanctioned within the EU for three MM indications. It is engineered to connect to the CD38 protein on MM cells, thereby prompting distinct anti-tumor activity.

Olivier Nataf, Sanofi's global head of oncology, expressed optimism regarding the CHMP's recommendation. He emphasized that this decision is a vital stride toward addressing unmet patient necessities in MM care and improving treatment outcomes across various stages of the disease. Nataf noted that if approved, the regimen would offer a new induction option for transplant-eligible patients, potentially enhancing long-term outcomes and deepening responses during a crucial phase of treatment.

The next steps involve the European Commission (EC) reviewing the CHMP's positive opinion to make a definitive decision on Sarclisa's application for this indication, a resolution anticipated in the upcoming months. This recommendation closely follows the EC's previous approval of Sarclisa with VRd for treating newly diagnosed MM in adults who do not qualify for autologous stem cell transplant.

Reflecting on the January approval, Nataf highlighted the positive implications for the 27 EU countries, which will gain access to a potentially transformative new combination regimen. This marks a significant advancement in Sanofi's mission to make a meaningful impact on MM treatment, offering fresh hope to patients and healthcare providers across the region.