CHMP recommends approval of Sarclisa for new indication

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sarclisa® (isatuximab) for a new indication. This recommendation is for the treatment of adult patients with relapsed multiple myeloma (MM) who have received at least one prior therapy, when used in combination with carfilzomib and dexamethasone (Kd).

The positive opinion from the CHMP is based on data from the Phase 3 IKEMA study. The study demonstrated a statistically significant improvement in progression-free survival (PFS) for patients receiving the Sarclisa combination therapy compared to the standard Kd regimen alone. The IKEMA trial enrolled 302 patients across 16 countries.

Multiple myeloma remains a serious and often relapsing cancer, making the development of new treatment options crucial. If approved by the European Commission, this recommendation will expand the use of Sarclisa and provide another therapeutic option for patients battling this disease.

The IKEMA study showed that the Sarclisa combination therapy reduced the risk of disease progression or death by 47% compared to standard Kd. While the overall response rate was similar between the treatment groups, the Sarclisa combination therapy arm showed a higher rate of complete response (CR) and minimal residual disease (MRD)-negative response, indicating deeper remissions.