- U.S. Food and Drug Administration (FDA) (https://voice.ons.org/topic/us-food-and-drug-administration-fda)
- Oncology Drug Research (https://voice.ons.org/topic/oncology-drug-research)
- Multiple Myeloma (https://voice.ons.org/topic/multiple-myeloma)
- Clinical Practice (https://voice.ons.org/topic/clinical-practice)
FDA Approves Isatuximab-Irfc for Multiple Myeloma
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](/sites/default/files/2018-03/FDA-Update-700_11_6.jpg)
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.
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).