Sarclisa FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 1, 2024.
FDA Approved: Yes (First approved March 2, 2020)
Brand name: Sarclisa
Generic name: isatuximab-irfc
Dosage form: Injection
Company: Sanofi
Treatment for: Multiple Myeloma
Sarclisa (isatuximab-irfc) is a CD38-directed cytolytic antibody used for the treatment of multiple myeloma.
- Sarclisa is indicated:
- in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
- in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
- in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).
Development timeline for Sarclisa
Further information
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