Officials with the FDA have approved isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone for adults with newly diagnosed multiple myeloma (MM) who are not eligible for autologous stem cell transplant (ASCT).1
Researchers from Centre Hospitalier Universitaire de Lille, in Lille, France and others evaluated the treatment’s efficacy in IMROZ (NCT03319667), an open-label, active-controlled phase 3 trial in 446 MM patients who were randomly assigned (3:2) to receive either isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone (Isa-VRd) or bortezomib, lenalidomide, and dexamethasone (VRd).
IMROZ demonstrated an improvement in progression-free survival (PFS) in the Isa-VRd arm with a 40% reduction in risk of disease progression or death (HR, 0.60; 95% CI, .44-.81; P=.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 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.
References
- FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. FDA. September 20, 2024. Accessed October 10, 2024. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-bortezomib-lenalidomide-and-dexamethasone-newly-diagnosed-multiple