FDA Approves Sanofi's Sarclisa Combo for Multiple Myeloma
The FDA has approved Sanofi’s Sarclisa (isatuximab) in combination with Onyx Pharmaceuticals’ Kyprolis (carfilzomib) and the corticosteroid dexamethasone for treating adults with relapsed or refractory multiple myeloma, who have received one to three previous lines of therapy.
The approval was supported by data from a phase 3 study in 302 participants that showed the combination therapy reduced the risk of disease progression or death by 45 percent vs. standard of care.
Sarclisa was previously approved by the FDA in March 2020 as a combination therapy with Celgene’s Pomalyst (pomalidomide) and dexamethasone for adults with relapsed or refractory multiple myeloma. who have received at least two previous lines of therapy including Celgene’s Revlimid (lenalidomide) and a proteasome inhibitor.