The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for isatuximab (Sarclisa®). The CHMP recommends this drug 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.
The European Commission (EC) will review the CHMP recommendation and a final decision on the Marketing Authorisation Application for isatuximab in the E.U. is expected in the coming months. This drug was approved in the United States (US) on March 2 in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
The CHMP positive opinion is based on data from ICARIA-MM, the first randomized Phase 3 trial to evaluate an anti-CD38 monoclonal antibody (mAB) in combination with pom-dex. In the ICARIA-MM study, Isatuximab added to pom-dex demonstrated a statistically significant improvement of progression free survival (PFS) with a median of 11.53 months compared to 6.47 months with pom-dex alone
Isatuximab combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone (60.4% vs. 35.3%, p<0.0001). 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.
The most common adverse reactions in patients who received isatuximab combination therapy were neutropenia (96%), infusion-related reactions (39%), pneumonia (31%), upper respiratory tract infection (57%) and diarrhea (26%). Serious adverse reactions that occurred in more than 5% of patients who received this drug combination therapy included pneumonia (25.3%) and febrile neutropenia (12.3%).