FDA approves isatuximab-irfc combination for certain adults with multiple myeloma
Click Here to Manage Email Alerts
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.
The FDA approved isatuximab-irfc in combination with bortezomib, lenalidomide and dexamethasone for treatment of certain adults with multiple myeloma.
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 plus bortezomib, lenalidomide and dexamethasone (VRd) or VRd alone.
PFS served as the primary endpoint.
The isatuximab-irfc cohort had a significant risk reduction for disease progression and death (HR = 0.6; 95% CI, 0.44-0.81).
The investigative arm did not reach median PFS. The VRd group had a median PFS of 54.3 months.
Common adverse events included upper respiratory tract infection, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia and COVID-19 infection.
The recommended IV dose of isatuximab-irfc is 10 mg/kg.
Read more about
Click Here to Manage Email Alerts