Issue: October, 2024
Fact checked byMindy Valcarcel, MS

Read more

September 20, 2024
1 min read
Save

FDA approves isatuximab-irfc combination for certain adults with multiple myeloma

Issue: October, 2024
Fact checked byMindy Valcarcel, MS
You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

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.

Generic FDA News infographic

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.