Isatuximab Plus VRd Earns FDA Priority Review in NDMM


The FDA has set a target action date of September 27, 2024, for a decision on the supplemental biologics license application of isatuximab plus bortezomib, lenalidomide, and dexamethasone.

Multiple myeloma cells: © David A Litman -

Multiple myeloma cells: © David A Litman -

  • The FDA has granted priority review to the supplemental biologics license application (sBLA) for isatuximab (Sarclisa) plus bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (VRd) for the treatment of transplant-ineligible, newly diagnosed multiple myeloma (NDMM).
  • The approval would make isatuximab the first anti-CD38 therapy plus standard-of-care VRd for transplant-ineligible, newly diagnosed myeloma.
  • If approved, this would be the third indication for isatuximab.

Isatuximab plus VRd has been granted priority review by the FDA for the treatment of transplant-ineligible NDMM. A Prescription Drug User Fee Act target action date of September 27, 2024, has been set. The European Union is also reviewing a regulatory submission.1

The priority review designation directs more resources and attention to applications for drugs that would provide significant improvements to the safety or effectiveness of treatments.

If approved, isatuximab would be the first anti-CD38 therapy in combination with VRd for this intent-to-treat population, and it would be the third indication for isatuximab.

“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 [isatuximab] 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 and global head of development at Sanofi, in a press release.

The sBLA is supported by the phase 3 IMROZ trial (NCT03319667). In December 2023, it was announced that the trial met its primary end point of progression-free survival (PFS).2

IMROZ enrolled 475 patients with transplant-ineligible, NDMM and randomized them to receive VRd with or without isatuximab.3 PFS was the study’s primary end point, and secondary end points included complete response (CR) rate, minimal residual disease (MRD) negativity rate for patients with a CR, 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 in MRD-negative patients, incidence of adverse events, and pharmacokinetics.

Patients were required to have an ECOG performance status of less than 2, adequate organ values, not received prior treatments for myeloma, and not have any other ongoing health conditions incompatible with the study objectives.

Further results will be presented during the 2024 American Society of Clinical Oncology Annual Meeting taking place on May 31 to June 4, 2024, and the 2024 European Hematology Association Annual Congress on June 13 to 16, 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 28, 2024.
2. 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 28, 2024.
3. Clinical benefit of SAR650984, bortezomib, lenalidomide, and dexamethasone combination in NDMM patients not eligible for transplant. Updated April 8, 2024. Accessed May 28, 2024.
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