Sanofi’s Sarclisa accepted for FDA priority review
Betsy Goodfellow | May 29, 2024 | News story | Medical Communications | FDA, Oncology, Sanofim, Sarclisa, multiple myeloma, priority review
Sanofi has announced that the US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for a priority review. The application is for the investigational use of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide and dextamethasone (VRd) for the treatment of patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).
If it gains FDA approval, Sarclisa would become the first approved anti-CD38 therapy in combination with standard of care VRd for use in this indication.
The FDA has set a target action date of 27 September 2024, and a regulatory submission is also currently under review in the European Union (EU).
This sBLA follows positive results from the IMROZ phase 3 clinical study which assessed the drug for this indication. The trial met its primary endpoint at a planned interim analysis for efficacy, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to standard of care.
Dietmar Berger MD PhD, chief medical officer and global head of development at Sanofi, commented: “Despite recent advancements in multiple myeloma treatment, there remains a significant unmet need for new frontline therapies, particularly for transplant-ineligible patients who can face poor outcomes from the disease. The filing acceptances, as well as the FDA’s Priority Review designation, reinforce our confidence in Sarclisa as a potential best-in-class treatment and represent a critical step toward advancing this combination in a difficult-to-treat cancer.”
Betsy Goodfellow
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