The FDA has approved Sarclisa (isatuximab) as part of a first-line treatment regimen for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.
The nod marks the first anti-CD38 therapy combined with bortezomib, lenalidomide, and dexamethasone (VRd) for this patient group. The approval is based on data from the IMROZ phase 3 study, which demonstrated that adding Sarclisa to VRd significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 40% compared to standard-of-care VRd alone.
Sarclisa's approval for this indication marks its third in the U.S., and the first for newly diagnosed patients. The agency’s decision was evaluated under Priority Review.
The drug is now approved in over 50 countries, and Sanofi continues to advance the therapy through ongoing clinical trials, exploring new combinations and administration methods to broaden its application.
The treatment was first approved by the FDA in 2020 for use in combination with pomalidomide and dexamethasone to treat adults with relapsed refractory multiple myeloma who had undergone at least two prior therapies.
