(RTTNews) - Sanofi (SNYNF, SNY) said Monday that the European Commission approved Sarclisa or isatuximab in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy. It marks the second EC approval of Sarclisa in combination with a standard of care regimen in less than 12 months.
The approval was based on Phase 3 IKEMA study demonstrating 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.
The European Commission approval follows the U.S. Food and Drug Administration approval of Sarclisa for a similar indication in March 2021.
In June 2020, Sanofi said Sarclisa received EC approval in combination with another standard of care regimen, pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory MM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.
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