FDA Approves Isatuximab-irfc for Multiple Myeloma
On March 2, 2020, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa®) 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 three 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 IV infusion every week for four weeks followed by every two weeks in combination with pomalidomide and dexamethasone until disease progression or unacceptable toxicity.
This review used the Assessment Aid (https://www.fda.gov/about-fda/oncology-center-excellence/assessment-aid), a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was approved approximately three 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 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics).
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 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate) at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov (mailto:OncProjectFacilitate@fda.hhs.gov).
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