Sanofi’s Sarclisa (isatuximab) has been approved by the European Commission (EC) to treat newly diagnosed multiple myeloma (MM).
The drug has been authorised for use 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.
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 is designed to bind to the CD38 protein on MM cells and induce distinct anti-tumour activity. The drug is already approved in the EU across three other MM indications, including in combination VRd to treat newly diagnosed MM in adults who are not eligible for autologous stem cell transplant.
The EC’s latest decision means that Sarclisa is now approved in the EU across all lines of therapy, regardless of transplant eligibility, and follows a recent recommendation from the European Medicines Agency’s human medicines committee.
The new authorisation was based on results from part one of the phase 3 German-speaking Myeloma Multicenter Group (GMMG)-HD7 study, in which Sarclisa-VRd was associated with a statistically significant minimal residual disease (MRD) negativity benefit at the end of the 18-week induction period.
There was also a statistically significant and clinically meaningful improvement in progression-free survival in patients treated with Sarclisa-VRd during induction, regardless of the maintenance therapy received, and 53.1% of patients receiving Sarclisa-VRd and 38% in the study’s control arm experienced continued MRD negativity, defined as MRD negativity persisting from post-induction to post-transplant.
Commenting on the latest authorisation, Olivier Nataf, global head of oncology at Sanofi, said: “We have been on a mission to accelerate Sarclisa’s clinical development programme with the hope to bring this important medicine to as many people as possible living with MM.
“[This] decision represents a prime example of those efforts, and most importantly, paves the way for Sarclisa to potentially become accessible to even more patients in the EU, regardless of transplant eligibility or line of therapy.”