Janssen’s Darzalex (daratumumab) has secured FDA approval in combination with lenalidomide and dexamethasone for the treatment of newly diagnosed multiple myeloma in patients who are not eligible for autologous stem cell transplant (ASCT), the company has confirmed.
The approval, which was awarded through the US regulator’s Real-Time Oncology Review pilot programme, was based on Phase 3 data which demonstrated that, at a median follow-up of 28 months after initial treatment, the combo “significantly reduced” the risk of disease progression or death by 44% compared to lenalidomide a
