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FDA Approves Frontline Daratumumab Regimen for Transplant-Eligible Myeloma

Gina Columbus @ginacolumbusonc
Published: Thursday, Sep 26, 2019

The FDA has approved daratumumab (Darzalex) in combination with bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).1



  1. Genmab Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone for Frontline Multiple Myeloma. Genmab. Published September 26, 2019. Accessed September 26, 2019.
  2. Moreau P, Attal M, Hulin C, et al. Phase 3 randomized study of daratumumab (DARA) + bortezomib/thalidomide/dexamethasone (D-VTd) vs VTd in transplant-eligible (TE) newly diagnosed multiple myeloma (NDMM): CASSIOPEIA Part 1 results. J Clin Oncol.2019;37(suppl; abstr 8003). doi: 10.1200/JCO.2019.37.15_suppl.8003.
  3. Sonneveld P, Attal M, Perrot A, et al. Daratumumab plus bortezomib, thalidomide, and dexamethasone (D-VTd) in transplant-eligible newly diagnosed multiple myeloma (NDMM): subgroup analysis of high-risk patients (Pts) in CASSIOPEIA. Presented at: 17th International Myeloma Workshop; September 12-15, 2019; Boston, MA. Abstract OAB-003.

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