European regulators have issued a green light for use of Sanofi's Sarclisa (isatuximab) to treat adults with relapsed and refractory multiple myeloma.
The decision follows data showing that Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) significantly cut the risk of progression or death by 40% versus pom-dex alone.
It allows physicians to prescribe the drug - a monoclonal antibody (mAb) that binds to a specific epitope on the CD38 receptor of MM cells - for adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
Multiple myeloma is the second most common blood cancer, with around 40,000 new cases per year in Europe.
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,” said John Reed, global head of Research and Development at Sanofi.
“Sarclisa in combination with pom-dex demonstrated median progression-free survival of nearly one year, a five-month improvement over pom-dex alone, in patients who had already failed at least two prior therapies.”