Daratumumab Combination Therapy Granted Priority Review in Multiple Myeloma
Posted: Monday, June 10, 2019
The U.S. Food and Drug Administration (FDA) recently granted a Priority Review for a supplemental Biologics License Application for the use of daratumumab in combination with bortezomib/thalidomide/dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are candidates for autologous stem cell transplantation (ASCT). The FDA assigned a Prescription Drug User Fee Act target date of September 26, 2019, to make a decision on daratumumab in this indication. Daratumumab is a human immunoglobulin G1k monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells.
The supplemental Biologics License Application submission is based on data from the phase III CASSIOPEIA study (ClinicalTrials.gov identifier NCT02541383) of daratumumab in combination with bortezomib/thalidomide/dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are candidates for ASCT. Data from the trial were presented at the 2019 American Society of Clinical Oncology Annual Meeting (Abstract 8003).
CASSIOPEIA is a randomized, open-label, multicenter study including 1,085 newly diagnosed patients with previously untreated symptomatic multiple myeloma who are eligible for high-dose chemotherapy and stem cell transplantation. In the first part of the study, patients were randomly assigned to receive induction and consolidation treatments with daratumumab combined with bortezomib/thalidomide/dexamethasone or bortezomib/thalidomide/dexamethasone alone. The primary endpoint is the proportion of patients achieving a stringent complete response.
In the second part of the study, patients who achieved a response will undergo a second randomization to receive either maintenance treatment of daratumumab at 16 mg/kg every 8 weeks for up to 2 years or observation. The primary endpoint of this part of the study is progression-free survival.
