European Commission approves isatuximab for relapsed and refractory myeloma patients

 

The European Commission (EC) has approved isatuximab (Sarclisa®) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

Isatuximab is a monoclonal antibody (mAb) that binds to a specific epitope on the CD38 receptor of MM cells.

In the Phase 3 ICARIA-MM study, Isatuximab added to pom-dex demonstrated a statistically significant improvement of progression-free survival (PFS), with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone. This combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone. In additional analyses, Isatuximab combination therapy compared to pom-dex alone showed a treatment benefit consistent across select subgroups reflective of real-world practice, including patients with high risk cytogenetics, those aged 75 years and older, patients with renal insufficiency and patients who were refractory to lenalidomide.

“As patients experience relapse of their multiple myeloma or become refractory to their current therapy, they become more difficult to treat with increasingly poor prognoses. In the ICARIA-MM trial, isatuximab combination therapy showed a treatment benefit consistent across relapsed and refractory multiple myeloma subgroups,” said Philippe Moreau, M.D., Department of Hematology, University Hospital of Nantes, France. “Isatuximab offers an important new treatment option and a potentially new standard of care for these patients with relapsed, refractory disease.”