The approval of Sarclisa and pom-dex combination is for people who had at least two prior therapies including lenalidomide and a proteasome inhibitor and have shown disease progression on the last therapy.
Sanofi had already secured approval for the combination for the same indication in the US.
Sanofi research and development global head John Reed said: “The EC approval of Sarclisa represents an important additional therapeutic option and may set a new standard of care for myeloma patients in Europe who are in need of new effective treatments because their disease has returned or they have become refractory to their previous treatment.”
Sarclisa is a monoclonal antibody (mAb). which has been designed to bind to a specific epitope on the CD38 receptor of multiple myeloma cells. It has been designed to have various mechanisms of action, including programmed tumour cell death, and immunomodulatory activity.
The French pharma company got the EC approval of the anti-CD38 monoclonal antibody based on the findings of the ICARIA-MM phase 3 trial. The Sarclisa and pom-dex combination delivered a statistically significant improvement of progression-free survival (PFS), with a median PFS of 11.53 months, in comparison to 6.47 months with pom-dex alone.
Furthermore, the combination therapy showed a significantly greater overall response rate compared to treatment with only pom-dex.
University Hospital of Nantes, France department of hematology Philippe Moreau, said: “As patients experience relapse of their multiple myeloma or become refractory to their current therapy, they become more difficult to treat with increasingly poor prognoses. In the ICARIA-MM trial, Sarclisa combination therapy showed a treatment benefit consistent across relapsed and refractory multiple myeloma subgroups.
“Sarclisa offers an important new treatment option and a potentially new standard of care for these patients with relapsed, refractory disease.”
Sanofi has been evaluating anti-CD38 monoclonal antibody in various ongoing phase 3 clinical trials in combination with current standard treatments across the multiple myeloma treatment continuum. The blood cancer drug is also being studied for the treatment of other hematologic malignancies and solid tumors.