FDA Approves Daratumumab-Based Quadruplet Regimen for Transplant-Eligible Myeloma

The U.S. Food and Drug Administration (FDA) approved the quadruplet regimen consisting of daratumumab, bortezomib, thalidomide, and dexamethasone to treat adult patients with newly diagnosed multiple myeloma who are eligible for autologous hematopoietic cell transplantation.

This approval is based on data from the open-label, randomized phase III CASSIOPEIA trial, which compared induction and consolidation treatment with either daratumumab 16 mg/kg plus bortezomib, thalidomide, and dexamethasone (DVTd) or bortezomib, thalidomide, and dexamethasone (VTd) alone. After a median follow-up of 18.8 months (range = 0-32.2), DVTd was associated with a 53% reduction in the risk of progression or death compared to VTd alone (p<0.0001). DVTd also appeared to be associated with higher rates of stringent complete response at 100 days post-transplant (28.9% vs. 20.3%; p value not reported).

There were no significant differences in the number or type of serious adverse events (AEs) between the two arms, but AEs that occurred at least 5% more frequently in the DVTd arm than the VTd arm included infusion reactions, nausea, neutropenia, thrombocytopenia, lymphopenia, and cough.

The combination was granted priority review.

Source: FDA press release, September 26, 2019.

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