FDA Approves Combination Treatment for Frontline Multiple Myeloma

Daratumumab was approved based on results from part one of the Phase III CASSIOPEIA study.

Officials from the FDA have approved the use of Genmab’s daratumumab (Darzalex) in combination with bortezomib, thalidomide and dexamethasone (VTd) as treatment for patients newly diagnosed with multiple myeloma. These patients have to be qualified for autologous stem cell transplant (ASCT).1

Daratumumab was approved based on results from part one of the Phase III CASSIOPEIA study. 1,085 newly diagnosed patients were randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or bortezomib, thalidomide and dexamethasone alone. The primary endpoint is the number of patients that achieve a stringent Complete Response (sCR).1

Daratumumab is the first CD38-directed antibody approved in the world and is the only CD38-directed antibody approved to treat multiple myeloma. CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. The therapeutic medicine binds to CD38 and inhibits tumor cell growth, causing myeloma cell death.2

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell found in the bone marrow, known as plasma cells. When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow.2


  • Genmab announces U.S. FDA approval of darzalex (daratumumab) in combination with bortezomib, thalidomide, and dexamethasone for frontline multiple myeloma [news release]. Copenhagen, Denmark: Genmab News; September 26, 2019. https://ir.genmab.com/news-releases/news-release-details/genmab-announces-us-fda-approval-darzalexr-daratumumab- Accessed September 26, 2019.
  • New DARZALEX® (daratumumab) data from GRIFFIN study show high response rate and depth of response in patients with newly diagnosed multiple myeloma who are transplant-eligible [news release]. Boston, MA: Janssen; September 15, 2019. https://www.janssen.com/new-darzalex-daratumumab-data-griffin-study-show-high-response-rate-and-depth-response-patients. Accessed September 26, 2019.