The Food and Drug Administration (FDA) has expanded the approval of Darzalex (daratumumab; Janssen Biotech) to include use in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
The approval was based on data from the phase 3 trial MAIA study. The trial compared the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in patients with newly diagnosed multiple myeloma who are not candidates for high dose chemotherapy and ASCT (N=737).
Results showed a 44% reduction in the risk of disease progression or death in patients treated with daratumumab in combination with lenalidomide and dexamethasone compared with those treated with lenalidomide and dexamethasone (hazard ratio [HR] 0.56; 95% CI 0.43-0.73; P <.0001); median PFS had not been reached in the daratumumab combination arm and was 31.9 months in the lenalidomide and dexamethasone arm.
“The combination of lenalidomide and dexamethasone is broadly used by newly diagnosed patients with multiple myeloma ineligible for ASCT in the United States. We are extremely pleased that physicians can now offer their patients the option to add Darzalex to this regimen in the US,” said Jan van de Winkel, PhD, Chief Executive Officer of Genmab.
Darzalex, a CD38-directed cytolytic antibody, is also approved for the treatment of multiple myeloma: as combination therapy with bortezomib, melphalan, and prednisone in newly-diagnosed patients who are ineligible for autologous stem cell transplant; as combination therapy with lenalidomide and dexamethasone, or bortezomib and dexamethasone, in patients who have received ≥1 prior therapy; as combination therapy with pomalidomide and dexamethasone in patients who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor (PI); or as monotherapy in patients who have received ≥3 prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
For more information visit darzalex.com.