FDA approves isatuximab-irfc for multiple myeloma
On March 2, 2020, the Food and Drug Administration 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), a multicenter, multinational, randomized, open-label, two-arm, phase 3 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 randomized (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% 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 diarrhea.
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.
View full prescribing information for SARCLISA.
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. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
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