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FDA Grants Approval to Isatuximab With Bortezomib, Lenalidomide, and Dexamethasone for Patients With Newly Diagnosed Multiple Myeloma Not Eligible for ASCT
On September 20th, 2024, the US Food and Drug Administration (FDA) granted approval to isatuximab-irfc (isatuximab) with bortezomib, lenalidomide, and dexamethasone for adult patients with newly diagnosed multiple myeloma (MM) who are not eligible for autologous stem cell transplant (ASCT). This approval was based on efficacy results from the IMROZ trial.
This open-label, randomized, active-controlled phase 3 trial included patients with newly diagnosed MM who were not eligible for ASCT, and enrollment was limited to patients 80 years old and younger. A total of 446 patients were randomized on a 3-to-2 basis to receive either isatuximab with bortezomib, lenalidomide, and dexamethasone or bortezomib, lenalidomide, and dexamethasone.
Investigators noted the main efficacy outcome measure was progression-free survival (PFS), as assessed by an independent review committee based on International Myeloma Working Group (IMWG) criteria. The IMROZ study demonstrated an improvement in PFS in the isatuximab with bortezomib, lenalidomide, and dexamethasone cohort with a 40% reduction in risk of disease progression or death (hazard ratio [HR] 0.60 [95% [confidence interval] CI, 0.44 to 0.81]; P = 0.0009). The median PFS was not reached in the isatuximab with bortezomib, lenalidomide, and dexamethasone arm and was 54.3 months (95% CI, 45.2 to NR) in the bortezomib, lenalidomide, and dexamethasone arm.
Researchers noted the most common adverse reactions (≥20%) to be 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.
Source:
FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. US Food and Drug Administration. Published online September 20, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-bortezomib-lenalidomide-and-dexamethasone-newly-diagnosed-multiple
