FDA Approves Isatuximab Plus VRd for Newly Diagnosed Myeloma

The FDA approved isatuximab-irfc (Sarclisa) plus bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone—a combination referred to as Isa-VRd—for the treatment of adults with newly diagnosed multiple myeloma who are not eligible to undergo an autologous stem cell transplant (ASCT), the agency announced.

The approval was based on findings from the randomized, phase III IMROZ clinical trial (NCT03319667). The study included 446 patients under the age of 80 who had newly diagnosed myeloma and were ineligible for ASCT. They were randomly assigned 3:2 to receive either Isa-VRd or bortezomib, lenalidomide, and dexamethasone (VRd).

The main goal of the trial was to measure independently reviewed progression-free survival (PFS) based on International Myeloma Working Group criteria. Findings showed that the Isa-VRd group had a 40% reduction in the risk of disease progression or death compared to the VRd group (hazard ratio of 0.60 [95% CI: 0.44, 0.81]; p-value 0.0009). Additionally, the median PFS was not reached (NR) in the Isa-VRd arm (95% CI: NR, NR), whereas it was 54.3 months in the VRd arm (95% CI, 45.2, NR).

Isatuximab was initially approved in combination with pomalidomide and dexamethasone for previously treated myeloma. Then, the drug (which is administered intravenously) was approved again in March 2021 in combination with carfilzomib (Kyprolis) and dexamethasone for relapsed or refractory myeloma.

The most common adverse events that occurred in ≥20% were: upper respiratory tract infection, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia, musculoskeletal pain, cataract, constipation, peripheral edema, rash, infusion-related reaction, insomnia, and COVID-19 infection.

Reference

FDA approves FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. FDA. September 20, 2024. Accessed September 20, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-bortezomib-lenalidomide-and-dexamethasone-newly-diagnosed-multiple?utm_medium=email&utm_source=govdelivery