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  6. FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
  1. Resources for Information | Approved Drugs

FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

On September 20, 2024, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).

Full prescribing information for Sarclisa will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was evaluated in IMROZ (NCT03319667), an open-label, randomized, active-controlled phase 3 trial in patients with newly diagnosed multiple myeloma who were not eligible for ASCT. Enrollment was limited to patients 80 years of age and younger. A total of 446 patients were randomized (3:2) to receive either isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone (Isa-VRd) or bortezomib, lenalidomide, and dexamethasone (VRd).

The main efficacy outcome measure was progression-free survival (PFS) as assessed by an independent review committee based on International Myeloma Working Group criteria. IMROZ demonstrated an improvement in PFS in the Isa-VRd arm with a 40% reduction in risk of disease progression or death (hazard ratio 0.60 [95% CI: 0.44, 0.81]; p-value 0.0009); the median PFS was not reached (NR) (95% CI: NR, NR) in the Isa-VRd arm and was 54.3 months (95% CI: 45.2, NR) in the VRd arm.

The most common adverse reactions (≥20%) were upper respiratory tract infection, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia, and COVID-19 infection.

The recommended isatuximab-irfc dose is 10 mg/kg actual body weight administered as an intravenous infusion. See the prescribing information for the dosage recommendations for the other drugs.

Expedited Programs

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X: @FDAOncology.

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