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# Sanofi’s Sarclisa OK’d for Multiple Myeloma
- URL: https://www.fdaweb.com/sanofis-sarclisa-okd-for-multiple-myeloma/
- Published: 2024-09-20T12:00:00.000Z
- Updated: 2026-09-14T14:41:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157825

FDA has approved a Sanofi-Aventis supplemental BLA for Sarclisa (isatuximab-irfc) for use with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.

Approval was based on data from the IMROZ (NCT03319667) Phase 3 trial in 446 patients who were randomized to receive either isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone or bortezomib, lenalidomide, and dexamethasone, according to an FDA [news release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-bortezomib-lenalidomide-and-dexamethasone-newly-diagnosed-multiple?utm%5Fmedium=email&utm%5Fsource=govdelivery). Patients taking isatuximab-irfc saw a 40% reduction in their risk of disease progression or death compared to those in the comparator group,it says.

Regarding safety, FDA says the most common adverse reactions were 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.

Sarclisa is described as a monoclonal antibody that binds to a specific epitope on the CD38 receptor on multiple myeloma cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death and immunomodulatory activities, Sanofi says.

Sarclisa was initially approved in 2020 for combination use with pomalidomide and dexamethasone for treating adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.