FDA Approves Daratumumab Combination for First-Line Treatment of Transplant-Eligible Patients with Multiple Myeloma

October 2019, Vol 10, No 5 - FDA Approvals, News & Updates


On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen Biotech), in combination with bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone, for first-line treatment of multiple myeloma in patients eligible for autologous stem-cell transplant (ASCT). In June 2019, the FDA approved the combination of daratumumab plus lenalidomide (Revlimid) and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT. The FDA granted this application a priority review.

This approval was based on an open-label, randomized, active-controlled phase 3 clinical trial that compared induction and consolidation treatments with daratumumab plus bortezomib, thalidomide, and dexamethasone (DVTd) versus bortezomib, thalidomide, and dexamethasone (VTd) alone in patients with newly diagnosed multiple myeloma who are eligible for ASCT.

The efficacy measures were progression-free survival (PFS), stringent complete response at 100 days post-ASCT, and complete response rate at day 100 post-ASCT. At a median follow up of 18.8 months, the median PFS had not been reached in either arm. However, DVTd reduced the risk for disease progression or death by 53% compared with VTd alone (hazard ratio, 0.47; 95% confidence interval, 0.33-0.67; P <.0001). At day 100 post-ASCT, the stringent complete responses were 28.9% with DVTd versus 20.3% with VTd alone.

The most common (≥20%) adverse events 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 adverse events in the 2 arms.