Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA has approved isatuximab-irfc (Sarclisa, Sanofi-Aventis) with bortezomib, lenalidomide and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for an autologous stem cell transplant (ASCT).
Efficacy was evaluated in IMROZ (ClinicalTrials.gov. Identifier: 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 for disease progression or death (hazard ratio, 0.60; 95% CI, 0.44-0.81; P=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 months to 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 full prescribing information for isatuximab-irfc will be posted at a later date here.
Based on a press release from the FDA.