The FDA’s Oncologic Drugs Advisory Committee unanimously voted that ciltacabtagene autoleucel (cilta-cel; Carvykti) offers more benefits than risks for treating adult patients with relapsed/refractory multiple myeloma who have had at least one prior therapy. This decision was influenced by results from the phase 3 CARTITUDE-4 trial, which showed that cilta-cel significantly improved progression-free survival (PFS) compared to standard treatments including pomalidomide plus bortezomib and dexamethasone, or daratumumab plus pomalidomide and dexamethasone.

CARTITUDE-4 was an open-label, randomized study enrolling patients with multiple myeloma who had undergone 1 to 3 prior lines of therapy, were refractory to lenalidomide, and had suitable performance status. Patients were assigned to either receive cilta-cel or standard of care, which included physician’s choice of pomalidomide plus bortezomib and dexamethasone or daratumumab plus pomalidomide and dexamethasone. Cilta-cel demonstrated an 85% overall response rate, including 58% achieving stringent complete response, compared to 67% in the standard care group.

Reference: Ryan C. FDA ODAC Committee Votes Unanimously in Favor of Benefit-Risk Profile of Cilta-Cel in Early R/R Myeloma. OncLive. Updated March 15, 2024. Accessed April 5, 2024. https://www.onclive.com/view/fda-odac-committee-votes-unanimously-in-favor-of-benefit-risk-profile-of-cilta-cel-in-early-r-r-myeloma