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Isatuximab combination therapy approved by the European Commission
By Claire Baker
On June 2, 2020, the combination of isatuximab (isa) with pomalidomide and dexamethasone (pom-dex) received approval from the European Commission for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM).1
This decision was based on promising data from the phase III ICARIA-MM study (NCT02990338), which uncovered a significantly improved progression-free survival rate in patients receiving isa in combination with pom-dex vs pom-dex alone. In adult patients with RRMM, the triplet combination regimen significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone. Read the MM Hub coverage of the ICARIA-MM trial here.
For further information on the indications of isa + pom-dex in this setting, read the European Medicines Agency’s Committee for Medicinal Products for Human Use positive opinion article on the MM Hub here.
SanofiGenzyme. European Commission approves Sarclisa® (isatuximab) for adults with relapsed and refractory multiple myeloma. https://www.sanofigenzyme.com/en/about-us/newsroom/2020/2020-06-02-11-50-00 . Published June 2, 2020. Accessed June 3, 2020.
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