Isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone is approved by the USFDA for newly diagnosed multiple myeloma

On September 20, 2024, the Food and Drug Administration sanctioned isatuximab-irfc (Sarclisa, Sanofi-Aventis U.S. LLC) in conjunction with bortezomib, lenalidomide, and dexamethasone for people with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).

Efficacy and Safety

The efficacy was assessed in IMROZ (NCT03319667), an open-label, randomized, active-controlled phase 3 trial involving patients with newly diagnosed multiple myeloma who were ineligible for ASCT. Enrollment was restricted to patients aged 80 years and below. A total of 446 patients were randomized in a 3:2 ratio to receive either isatuximab-irfc combined with bortezomib, lenalidomide, and dexamethasone (Isa-VRd) or bortezomib, lenalidomide, and dexamethasone (VRd).

The primary effectiveness endpoint was progression-free survival (PFS), evaluated by an independent review committee according to International Myeloma Working Group guidelines. IMROZ exhibited an enhancement in progression-free survival (PFS) in the Isa-VRd cohort, indicating a 40% reduction in the risk of disease progression or mortality (hazard ratio 0.60 [95% CI: 0.44, 0.81]; p-value 0.0009); the median PFS was not attained (NR) (95% CI: NR, NR) in the Isa-VRd cohort, while it was 54.3 months (95% CI: 45.2, NR) in the VRd cohort.

The predominant adverse events (≥20%) included upper respiratory tract infection, diarrhea, lethargy, peripheral sensory neuropathy, pneumonia, musculoskeletal discomfort, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia, and COVID-19 infection.

The advised dosage of isatuximab-irfc is 10 mg/kg of real body weight, delivered via intravenous infusion. Refer to the prescribing material for dosage recommendations of the other medications.