The FDA approved isatuximab-irfc in combination with bortezomib, lenalidomide and dexamethasone for treatment of certain adults with multiple myeloma.
The indication applies to adults with newly diagnosed disease who are not eligible for autologous stem cell transplantation.
Isatuximab-irfc (Sarclisa, Sanofi) is a CD38-directed monoclonal antibody.
The FDA based its approval on results from a randomized phase 3 trial (IMROZ), which Healio previously reported on.
The open-label trial enrolled 446 adults aged 80 years or younger. Researchers randomized patients 3:2 to receive either isatuximab-irfc
