FDA Approves Isatuximab-Irfc With Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

Efficacy was evaluated in IMROZ (NCT03319667), an open-label, randomized, active-controlled, phase III trial in patients with newly diagnosed multiple myeloma who were not eligible for ASCT. Enrollment was limited to patients 80 years of age and younger. A total of 446 patients were randomized 3:2 to receive either isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone (isa-VRd) or bortezomib, lenalidomide, and dexamethasone (VRd) alone.

The main efficacy outcome measure was progression-free survival (PFS), as assessed by an independent review committee based on International Myeloma Working Group criteria. IMROZ demonstrated an improvement in PFS in the isa-VRd arm with a 40% reduction in risk of disease progression or death (hazard ratio 0.60 [95% CI = 0.44, 0.81]; p = 0.0009); the median PFS and 95% CI were not reached (NR) in the Isa-VRd arm and were 54.3 months (95% CI = 45.2, NR) in the VRd arm.

The most common adverse reactions reported in at least 20% of patients were upper respiratory tract infections, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataracts, constipation, peripheral edema, rash, infusion-related reactions, insomnia, and COVID-19 infections.

The recommended isatuximab-irfc dose is 10 mg/kg per actual body weight, administered as an IV infusion. See the full prescribing information on Drugs@FDA (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm) for the dosage recommendations for the other drugs.

The applicant used the Assessment Aid (https://www.fda.gov/about-fda/oncology-center-excellence/assessment-aid) to facilitate the FDA’s review. The FDA granted the application priority review and orphan drug designation. FDA’s expedited programs are described 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 800-FDA-1088.

For assistance with single-patient applications for investigational oncology products, healthcare professionals may contact the Oncology Center of Excellence’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).