FDA Approves Isatuximab-Irfc for Multiple Myeloma

April 01, 2021

On March 31, 2021, the U.S. Food and Drug Administration (FDA) approved (https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-isatuximab-irfc-multiple-myeloma) isatuximab-irfc (Sarclisa®) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

FDA Approves Isatuximab-Irfc for Multiple Myeloma

Efficacy and safety were evaluated in a multicenter, multinational, randomized, open-label, two-arm, phase III trial (IKEMA; NCT03275285) of 302 patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. Patients were randomized 3:2 to receive either isatuximab-irfc with carfilzomib and dexamethasone (Isa-Kd) or carfilzomib and dexamethasone (Kd). 

The main efficacy outcome measurement was progression-free survival (PFS) assessed by an independent response committee based on central laboratory data for M-protein and central radiologic imaging review using international myeloma working group criteria. Median PFS was not reached in the Isa-Kd arm and was 20.27 months (95% CI = 15.77, not reached) in the Kd arm (hazard ratio = 0.548; 95% CI = 0.366, 0.822; p = 0.0032), representing a 45% reduction in the risk of disease progression or death in patients treated with Isa-Kd compared to those treated with Kd. 
The most common adverse reactions (≥ 20%) were upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain. The most common hematology laboratory abnormalities (≥ 80%) were decreased hemoglobin, decreased lymphocytes, and decreased platelets. 

The recommended isatuximab-irfc dose with carfilzomib and dexamethasone is 10 mg/kg via IV infusion every week for four weeks followed by every two weeks until patients experience disease progression or unacceptable toxicity. 

View full prescribing information for isatuximab-irfc (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s003lbl.pdf)

The review used Assessment Aid (https://www.fda.gov/about-fda/oncology-center-excellence/assessment-aid), a voluntary submission from the applicant to facilitate FDA’s assessment. FDA approved the application three months ahead of its goal date. 

FDA granted the application 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 they suspect are associated with the use of any medicine or device to FDA’s MedWatch Reporting System (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 800-FDA-1088.  

For assistance with single-patient oncology investigational new drug applications, 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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