Isatuximab combination therapy receives positive opinion from EMA CHMP for the treatment of relapsed and refractory multiple myeloma

On March 27, 2020, the anti-CD38 agent, isatuximab, was granted positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of relapsed and refractory (R/R) multiple myeloma (MM; RRMM) in combination with pomalidomide and dexamethasone (pom-dex).

The decision was based on the positive data from the phase III ICARIA-MM trial (NCT02990338), which reported the favorable clinical activity of isatuximab 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. Read the MM Hub coverage of the ICARIA-MM trial here.

The CHMP recommends the combination of isatuximab with pom-dex for the treatment of adult patients with RRMM following prior treatment with two or more therapies including lenalidomide and a proteasome inhibitor whose disease has progressed on their last therapy. The final decision on the Marketing Authorization Application is with the European Commission  and is expected in the coming months.

The MM Hub recently covered the U.S. Food & Drug Administration (FDA) approval of isatuximab plus pom-dex for the same indication, read the full article here.