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FDA has approved Sarclisa in combination with Pomalidomide and Dexamethasone for adult patients with multiple myeloma


The Food and Drug Administration ( FDA ) hasapproved Sarclisa ( Isatuximab-irfc; Isatuximab ) 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 is 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 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 progression-free survival has represented a 40% reduction in the risk of disease progression or death in patients treated with Isa-Pd ( hazard ratio, HR 0.596; 95% CI: 0.44-0.81; p=0.0010 ).

Median progression-free survival 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 ( greater than or equal to 20% of patients ) were neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, and diarrhea.

The recommended Isatuximab 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. ( Xagena )

Source: FDA, 2020

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