On 2 March 2020, the US Food and Drug Administration (FDA) approved isatuximab-irfc (SARCLISA, sanofi-aventis U.S. LLC) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
ICARIA-MM (NCT02990338) is a multicentre, multinational, randomised, open-label, two-arm, phase III study in 307 patients with relapsed and refractory multiple myeloma who had received at least two prior therapies including lenalidomide and a proteasome inhibitor. Patients were randomised (1:1) to receive either isatuximab-irfc with pomalidomide and low-dose dexamethasone (Isa-Pd, 154 patients) or pomalidomide and low-dose dexamethasone (Pd, 153 patients).
The main efficacy outcome measure was progression-free survival (PFS) assessed by an independent committee based on central laboratory data for M-protein and central radiologic imaging review using International Myeloma Working Group criteria. The improvement in PFS represented a 40% reduction in the risk of disease progression or death in patients treated with Isa-Pd (HR 0.596; 95% confidence interval [CI]: 0.44-0.81; p = 0.0010). Median PFS for the patients who received Isa-Pd was 11.53 months (95% CI: 8.94-13.9) vs 6.47 months (95% CI: 4.47-8.28) for those who received Pd.
The most common adverse reactions (≥20% of patients) were neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, and diarrhoea.
The recommended isatuximab-irfc dose is 10 mg/kg as an intravenous infusion every week for 4 weeks followed by every 2 weeks in combination with pomalidomide and dexamethasone until disease progression or unacceptable toxicity.
Full prescribing information for SCARLISA is available here.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was approved approximately 3 months prior to the FDA goal date.
Isatuximab-irfc was granted orphan drug designation.
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.