The FDA has approved the anti-CD38 monoclonal antibody isatuximab-irfc, in combination with pomalidomide and dexamethasone, for adults with multiple myeloma (MM) who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor (PI).
This approval was based on results from the ICARIA-MM trial, a phase III study in 307 patients with relapsed/refractory MM who had been previously treated with lenalidomide and a PI. Patients were randomized to receive either:
- isatuximab-irfc with pomalidomide and low-dose dexamethasone (n=154)
- pomalidomide and low-dose dexamethasone (n=153)
Median progression-free survival in the isatuximab group was 11.5 months (95% CI 8.9-13.9), compared with 6.5 months (95% CI 4.5-8.3) in patients who received pomalidomide and low-dose dexamethasone. Patients treated with isatuximab had a 40% lower risk of disease progression or death during the duration of the study, compared with those who did not receive isatuximab.
The recommended dose of isatuximab-irfc is a 10-mg/kg intravenous infusion weekly for 4 weeks, followed by every 2 weeks in combination with pomalidomide and dexamethasone, continued until unacceptable toxicity or disease progression.
Adverse events reported in ≥20% of patients included neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, and diarrhea.
The FDA previously granted isatuximab-irfc orphan drug designation.
Source: FDA news release, March 2, 2020.
