The U.S. FDA has approved Johnson & Johnson’s (JNJ) Darzalex Faspro (daratumumab and hyaluronidase) along with bortezomib, lenalidomide, and dexamethasone (VRd) newly diagnosed multiple myeloma individuals who can’t receive an autologous stem cell transplant.
Efficacy was based on the open-label, active-controlled CEPHEUS trial based on overall minimal residual disease negativity rate and progression-free survival data.
The MRD negativity rate was 52.3% in the Darzalex Faspro-VRd arm and 34.8% in the VRd alone cohort. The PFS hazard ratio was 0.60.
