- FDA Announcements
FDA Approved NDMM Transplant Eligible: Daratumumab + Bortezomib, Thalidomide and Dexamethasone
Updated: Oct 16, 2021
On September 26, 2019, the Food and Drug Administration approved daratumumab (DARZALEX, Janssen) for 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).
Efficacy was investigated in CASSIOPEIA (NCT02541383), an open-label, randomized, active-controlled phase 3 study comparing induction and consolidation treatment with daratumumab 16 mg/kg in combination with bortezomib, thalidomide and dexamethasone (DVTd) to treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients with newly diagnosed multiple myeloma eligible for ASCT.
09/26/2019: FDA Approval