On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa®) with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation (ASCT).
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 for the dosage recommendations for the other drugs.
The applicant used the 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.
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 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 at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.