Another Drug Combo Approved for Multiple Myeloma

The FDA today approved Janssen’s daratumumab and hyaluronidase-fhij (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone, for patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation. Efficacy was evaluated in the PERSEUS trial, in which 709 patients ages 70 and younger were assigned to receive all the drugs or just bortezomib, lenalidomide, and dexamethasone. Treatment with daratumumab/hyaluronidase and the other agents yielded a 60% decrease in the risk of disease progression or death, as well as an improvement in progression-free survival, compared to the control arm.