The Janssen Pharmaceutical Companies of Johnson & Johnson received approval from the U.S. FDA for DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The approval is based on results from the Phase III study, which showed that DARZALEX-Rd significantly reduced the risk of disease progression or death by 44 percent compared to treatment with Rd alone. The application received approval through the FDA’s Real-Time Oncology Review (RTOR) pilot program.

“This approval of DARZALEX underscores the significant clinical benefit of this CD38 monoclonal antibody and our efforts to advance treatment paradigms to change the course of the disease,” said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “Importantly, this milestone also highlights the efficiency of the FDA’s Real-Time Oncology Review process, ensuring that proven treatment regimens, such as DARZALEX plus lenalidomide and dexamethasone, are made available to patients as soon as possible.”