FDA Grants Priority Review to Sarclisa Combo for Patients with Newly Diagnosed Multiple Myeloma Based on IMROZ Trial Findings


Sarclisa (isatuximab-irfc) could become the first anti-CD38 therapy indicated in combination with bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for a transplant.

Image credit: LASZLO | stock.adobe.com

Image credit: LASZLO | stock.adobe.com

Positive findings from the Phase III IMROZ clinical trial led to the FDA granting Priority Review to a supplemental Biologics License Application (sBLA) from Sanofi for Sarclisa (isatuximab-irfc) combined with bortezomib, lenalidomide, and dexamethasone (VRd) to treat transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM).1

Sarclisa is a targeted monoclonal antibody with two previous approvals for patients with relapsed and refractory multiple myeloma, which is the second most common type of blood cancer.2,3 Should the FDA approve the latest sBLA for Sarclisa, it would become the first anti-CD38 therapy indicated in combination with VRd for newly diagnosed patients who are ineligible for a transplant.

“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,” Dietmar Berger, MD, PhD, chief medical officer, global head of Development at Sanofi, said in a press release. “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.”1

The randomized, multi-center, open label IMROZ trial enrolled 484 transplant-ineligible patients with NDMM across 21 countries. Patients in the treatment cohort were administered Sarclisa via intravenous (IV) infusion at a dose of 10 mg/kg once weekly for five weeks through the first 42-day cycle and once every two weeks in cycles two to four combined with subcutaneous bortezomib, oral lenalidomide, and IV or oral dexamethasone. Sarclisa was then administered every two weeks from cycle five to 17 and every four weeks in cycles 18-plus during 28-day cycles combined with standard doses of lenalidomide and dexamethasone until disease progression, unacceptable safety, or patient decision to cease treatment.4

The trial’s primary endpoint is progression-free survival (PFS), with key secondary endpoints that include complete response rate; minimal residual disease (MRD) negativity rate for patients who achieved a complete response, very good partial response, or better rate; overall survival; overall response rate; time to progression; duration of response; time to first response; time to best response; PFS on next line of therapy; PFS by MRD status; sustained MRD negativity greater than or equal to 12 months rate; safety; pharmacokinetic profile; immunogenicity; disease-specific and generic health-related quality of life; disease- and treatment-related symptoms; health state utility; and health status.

The trial found that the Sarclisa combination achieved a statistically significant improvement in PFS compared with VRd alone in transplant-ineligible patients with NDMM. In terms of safety, the tolerability profile was consistent with prior findings regarding Sarclisa and VRd, with no new safety signals identified.4

“The IMROZ trial outcome is promising for patients with newly diagnosed multiple myeloma who are transplant-ineligible, as there remains a significant unmet need for potential new therapies,” IMROZ principal investigator Thierry Facon, MD, said in a press release. “First-line therapeutic options are critical for all patients, but especially for those who are transplant-ineligible, given attrition rates in subsequent lines of therapy.”4

IMROZ was the fourth Phase III trial of Sarclisa combinations in patients with NDMM that showed superiority compared with standard of care, which bolsters its potential as a best-in-class therapy, according to Sanofi. Data from the IMROZ trial will be featured in an oral presentation at the 2024 American Society of Clinical Oncology Annual Meeting and at the 2024 European Hematology Association Annual Congress.

The FDA assigned the sBLA for the combination with a Prescription Drug User Fee Act Date of September 27, 2024.1


1. Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma. News release. Sanofi. May 27, 2024. Accessed May 29, 2024.

2. FDA approves Sarclisa (isatuximab-irfc) for patients with relapsed multiple myeloma. News release. Sanofi-aventis U.S. LLC. March 2, 2020. Accessed May 29, 2024. https://www.sanofi.com/en/media-room/press-releases/2020/2020-03-02-19-51-16

3. Understanding SARCLISA. International Myeloma Foundation. Published June 2020. Accessed May 29, 2024. https://imf-d8-prod.s3.us-west-1.wasabisys.com/2020-06/U-Sarclisa.pdf

4. Sarclisa® (isatuximab) Phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant. News release. Sanofi. December 7, 2023. Accessed May 29, 2024. https://www.sanofi.com/en/media-room/press-releases/2023/2023-12-07-06-35-00-2792221

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