Sanofi’s Sarclisa (isatuximab) has been recommended by the European Medicines Agency’s human medicines committee as part of a combination treatment for newly diagnosed multiple myeloma (MM).
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be approved in combination with bortezomib, lenalidomide and dexamethasone (VRd) as an induction treatment for adults with newly diagnosed MM who are eligible for autologous stem cell transplant.
The recommendation was supported by positive results from part one of the phase 3 German-speaking Myeloma Multicenter Group (GMMG)-HD7 study, which showed that Sarclisa with VRd induction treatment significantly improved minimal residual disease negativity benefit and prolonged progression-free survival compared to VRd alone.
The second part of the study re-randomised patients to receive Sarclisa plus lenalidomide versus lenalidomide alone as a post-transplant maintenance therapy.
MM is the second most common blood cancer after non-Hodgkin lymphoma, with approximately 46,000 cases of the disease expected to be diagnosed in Europe this year.
Sarclisa, which is already approved in the EU across three MM indications, is designed to bind to the CD38 protein on MM cells and induce distinct anti-tumour activity.
Commenting on the latest decision on the drug, Olivier Nataf, global head, oncology, Sanofi, said: “The CHMP’s recommendation represents significant progress toward our ambition for Sarclisa, addressing unmet patient needs in MM care and making a meaningful difference in treatment outcomes at every stage of the disease across regions.
“If approved, this regimen would represent a new, important induction option for transplant-eligible patients, with the potential to improve long-term outcomes and deepen responses at a critical juncture in treatment.”
The European Commission (EC) will now review the CHMP’s positive opinion as it makes a final decision on Sarclisa in this indication, which is expected in the coming months.
The recommendation comes six months after the EC approved Sarclisa alongside VRd to treat newly diagnosed MM in adults who are not eligible for autologous stem cell transplant.
“With [this] 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 MM treatment,” Nataf said at the time of the January approval.