FDA Grants Priority Review to Sanofi’s Sarclisa in Combination Therapy with VRd for Treating Multiple Myeloma

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FDA’s priority review status was granted based on positive results from a Phase III study evaluating Sarclisa in combination with VRd in treating transplant-ineligible newly diagnosed multiple myeloma.

FDA has accepted Sanofi’s supplemental biologics license application (sBLA) for Sarclisa (isatuximab) and granted it priority review, Sanofi announced on May 27, 2024. In the sBLA, Sanofi is seeking approval for the use of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for treating patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM).

If approved in this indication, Sarclisa would be the first anti-CD38 therapy to be used in combination with VRd, a standard of care, in newly diagnosed patients who are ineligible for a transplant, Sanofi stated in a company press release. This would be the third indication for Sarclisa in multiple myeloma if the sBLA is approved. FDA has a target action date for its decision on Sept. 27, 2024. A regulatory submission for this same indication is also under review in the European Union (EU).

“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 [FDA’s] [p]riority [r]eview 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,” said Dietmar Berger, MD, PhD, chief medical officer, global head of development, Sanofi in the release.

Both the sBLA and the filing in the EU are based on positive results from a Phase III clinical study (IMROZ), which evaluated the investigational use of Sarclisa in combination with VRd. The study met its primary endpoint, as reported by the company in December 2023 (1). A planned interim analysis of efficacy data showed that Sarclisa in combination with VRd demonstrated a statistically significant improvement in progression-free survival (PFS) compared with VRd alone in transplant-ineligible patients with NDMM. Sanofi researchers also observed that the safety and tolerability of Sarclisa in the Phase III study were consistent with the established safety profile of Sarclisa and VRd.

Sarclisa, a monoclonal antibody (mAb), binds to a specific epitope on the CD38 receptor on multiple myeloma (MM) cells to induce distinct antitumor activity. Sanofi stated in its press release that “[i]t is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activities. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.”


Sarclisa is currently approved in more than 50 countries, including the United States and the EU, in combination with pomalidomide and dexamethasone for treating certain patients with relapsed refractory MM (RRMM) who have had two or more prior therapies, including lenalidomide and a proteasome inhibitor, and who progressed on last therapy. The mAb is also approved in 50 countries, including in the US, in combination with carfilzomib and dexamethasone, for treating patients with RRMM who have had one to three prior lines of therapy, and in the EU for patients with MM who have received at least one prior therapy.

Sarclisa is also in multiple ongoing Phase III clinical studies in combination with current standard treatments across different MM indications and is under investigation for treating other hematologic malignancies. According to Sanofi, the product’s safety and efficacy has not been evaluated by any regulatory authority outside of its approved indication.


1. Sanofi. Press Release: Sarclisa (isatuximab) Plus KRd Significantly Improved Rate of Minimal Residual Disease Negativity in Transplant-Eligible Patients with Newly Diagnosed Multiple Myeloma versus KRd Alone. Press Release, Dec. 11, 2023.

Source: Sanofi