Isatuximab combo to treat multiple myeloma

April 4, 2020 0 By FM

The US FDA has approved isatuximab-irfc (Sarclisa) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM).

The treatment is indicated for those who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. 

Isatuximab is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells.

In the ICARIA-MM study, isatuximab added to pom-dex demonstrated a statistically significant improvement in progression free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone (HR 0.596, 95% CI: 0.44-0.81, p=0.0010). The combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone..

Isatuximab has Orphan Drug Designation status from the FDA and the European Medicines Agency (EMA). 

The drug is also being evaluated in multiple ongoing phase 3 clinical trials in combination with current standard treatments for people with relapsed refractory or newly diagnosed multiple myeloma.