FDA Approves Darzalex® Combo for Transplant-Eligible Patients With Multiple Myeloma

The U.S. Food and Drug Administration (FDA) approved the combination of Darzalex® (daratumumab) plus Velcade® (bortezomib), thalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma (MM) who are eligible for autologous hematopoietic cell transplantation (AHCT).

The decision was based on results from the open-label, randomized, active-controlled, phase III CASSIOPEIA trial, which compared induction and consolidation treatment with daratumumab 16 mg/kg in combination with bortezomib, thalidomide, and dexamethasone versus bortezomib, thalidomide, and dexamethasone alone in 1,085 patients with newly diagnosed MM who were transplant-eligible.

Improved survival with the addition of daratumumab

The results indicated an improvement in progression-free survival (PFS) in those receiving the daratumumab combination. After a median follow-up of 18.8 months, the median PFS was not reached in either cohort.

The addition of daratumumab reduced the risk of progression or death by 53% compared with bortezomib, thalidomide, and dexamethasone alone (hazard ratio = 0.47; 95% CI, 0.33-0.67; P<0.0001). The stringent complete response rate at 100 days post-AHCT was 28.9% in the daratumumab cohort and 20.3% in the bortezomib, thalidomide, and dexamethasone alone group.

The most common adverse events (AEs) experienced by patients receiving daratumumab, bortezomib, thalidomide, and dexamethasone were infusion reactions, peripheral sensory neuropathy, constipation, asthenia, nausea, peripheral edema, neutropenia, thrombocytopenia, pyrexia, and paresthesia. There were no significant differences in the number or type of serious AEs experienced in the two treatment arms.