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# BLA for Multiple Myeloma Therapy Approved
- URL: https://www.fdaweb.com/bla-for-multiple-myeloma-therapy-approved/
- Published: 2020-03-02T12:00:00.000Z
- Updated: 2026-09-14T16:05:10.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5146219

FDA has approved a Sanofi BLA for Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for treating adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells, according to the company.

Approval is based on data from the ICARIA-MM study which showed that Sarclisa added to pom-dex demonstrated a statistically significant improvement in progression free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone. Sanofi says. The combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone, it says.

The most common adverse reactions (occurring in 20% or more of patients) in patients who received Sarclisa combination therapy were neutropenia (96%), infusion-related reactions (39%), pneumonia (31%), upper respiratory tract infection (57%) and diarrhea (26%), Sanofi says. Serious adverse reactions that occurred in more than 5% of patients on the combination therapy included pneumonia (25.3%) and febrile neutropenia (12.3%).