The FDA approved daratumumab (Darzalex, Janssen) in combination with VTd (bortezomib, thalidomide, dexamethasone) for newly diagnosed patients with multiple myeloma who are eligible for an autologous hematopoietic cell transplant (auto-HCT).
The approval is based on results from the two-part, phase 3 CASSIOPEIA study conducted by the Intergroupe Francophone du Myelome in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and Janssen. Part 1 of the study showed