Ssatuximab (Sarclisa, Sanofi) is used in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma.
In April, the FDA approved isatuximab (Sarclisa, Sanofi) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma.
Multiple myeloma is the second most common hematologic malignancy, affecting more than 130,000 patients in the United States, according to a Sanofi press release. Despite some available treatments, it remains incurable and has significant patient burden. Most patients will relapse or become refractory when their cancer no longer responds to therapy.
This was the second FDA approval for isatuximab in combination with standard-of-care therapies, following its approval in March 2020 in combination with pomalidomide and dexamethasone for relapsed refractory multiple myeloma. Isatuximab is a monoclonal antibody that binds to an epitope on the CD38 receptor on multiple myeloma cells. It works through several mechanisms of action, including apoptosis and immunomodulatory activity, according to the press release.
The new approval is based on data from the phase 3 IKEMA study, which enrolled 302 patients with relapsed multiple myeloma across 69 centers in 16 countries. Demographic and disease characteristics at baseline were balanced between the combination treatment group and the standard-of-care group. The researchers noted that they enrolled a difficult-to-treat patient population, including those who are elderly, have high cytogenetic risk, or renal impairment.
According to the press release, investigators found that isatuximab in combination with carfilzomib and dexamethasone reduced the risk of disease progression or death by 45% versus standard of care alone. At the time of the pre-planned interim analysis, the researchers said the median progression-free survival had not yet been reached.