The Food and Drug Administration (FDA) has approved Darzalex (daratumumab; Janssen) for the treatment of adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT).

The approval was based on data from the phase 3 CASSIOPEIA study which compared induction and consolidation treatment with Darzalex in combination with bortezomib, thalidomide (DVTd) and dexamethasone to treatment with bortezomib, thalidomide, and dexamethasone (VTd); a total of 1085 patients were randomized: 543 to the DVTd arm and 542 to the VTd arm. The primary end points of the study were the proportion of patients that achieved a stringent complete response (sCR) at Day 100 post-transplant and progression-free survival (PFS) after maintenance therapy (currently ongoing).

Results showed that at Day 100 post-transplant, 28.9% of the DVTd group achieved sCR vs 20.3% of the VTd group. At a median follow up of 18.8 months, the median PFS had not been reached in either arm, however an improvement in PFS was noted in the DVTd arm compared with the VTd arm. Treatment with DVTd resulted in a reduction in the risk of progression or death by 53% compared with VTd alone (HR 0.47; 95% CI: 0.33, 0.67; P <.0001).

“Today’s approval is an important step forward for patients with multiple myeloma,” said Jan van de Winkel, PhD, Chief Executive Officer of Genmab. “There are now 3 different treatment combinations that include Darzalex for patients newly diagnosed with multiple myeloma, whether they are eligible for ASCT or not.”


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Darzalex, a CD38-directed cytolytic antibody, is also approved for the treatment of adult patients with multiple myeloma in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant; in combination with bortezomib and dexamethasone in patients who have received at least 1 prior therapy; in combination with pomalidomide and dexamethasone in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor; and as monotherapy, in patients who have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

For more information visit janssen.com.