Sanofi: EC approves treatment for multiple myeloma

(CercleFinance.com) - The European Commission (EC) today approved Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adults with relapsed multiple myeloma who have received one to three prior therapies.


The group said that this is the "Second EU approval in less than 12 months for Sarclisa in combination with a standard of care regimen".

The EC approval is based on data from the Phase III IKEMA study, a randomised, multi-centre, open-label clinical trial that included 302 patients with relapsed multiple myeloma at 69 centres in 16 countries.

"Sarclisa added to standard of care carfilzomib and dexamethasone reduced risk of disease progression or death by 47% in patients who had relapsed after one to three prior therapies," Sanofi said.

Multiple myeloma is the second most common haematological cancer, with over 130,000 new cases diagnosed each year worldwide. In Europe, approximately 39,000 new cases are diagnosed each year.


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