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CompileKe Ke
On April 19, the European Commission (EC) approved Sanofi Sarclisa (isatuximab, ixatuximab) in combination with carfilzomib and dexamethasone (Kd) for recurrent multiple patients who have received at least one treatment Treatment of adult patients with myeloma (MM).
The EC's approval decision was made immediately following the US FDA's approval of Sarclisa for similar indications in March 2021.
According to Sanofi, this approval is based on data from the Phase 3 study IKEMA, which is a randomized, multi-center, open clinical trial involving 302 patients with recurrent MM from 69 centers in 16 countries.
The secondary endpoints of the IKEMA trial evaluated the depth of response of Sarclisa combination therapy compared with Kd therapy, including overall response rate (ORR), complete response (CR), very good partial response (VGPR) and minimal residual disease (MRD)-negative reaction.
In addition, the study found that the most common (≥20%) adverse reactions were infusion reactions (45.
Sarclisa is approved in the European Union, the United States, Switzerland, the United Kingdom, Canada, Australia, Japan, Russia, the United Arab Emirates, South Korea, Taiwan and Qatar in combination with pom-dex for the treatment of certain adult relapsed and refractory MM.
Reference source: European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma
