The FDA granted a new indication for daratumumab (Darzalex, Janssen/Genmab A/S) in combination with lenalidomide (Revlimid, Celgene) and dexamethasone (Rd) for the treatment of patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous hematopoietic cell transplant (HCT).
The new indication, approved through the FDA’s Real-Time Oncology Review pilot program, was based in part on data from the phase 3 MAIA study (N Engl J Med 2019;380[22]:2104-2115). At a