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.
View full prescribing information for isatuximab-irfc.
This review used the 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.
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 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 at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.
In collaboration with the FDA and as a service to our members, ONS provides updates on recent FDA approvals and other important FDA actions (e.g., updated safety information, new prescribing information) pertaining to therapies for patients with cancer. This allows the agency to inform oncologists and professionals in oncology-related fields in a timely manner. Included in the FDA updates is a link to the product label or to other sites for additional relevant clinical information. In supplying this information, ONS does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.