The U.S. FDA has approved Johnson & Johnson’s (JNJ) Darzalex Faspro (daratumumab and hyaluronidase) for a new indication for adults with high-risk smoldering multiple myeloma (SMM).
Efficacy was determined based on results from the open-label, randomized AQUILA trial of 390 patients with high-risk SMM. The proportion of patients free of disease progression or death was 63.1% for those on the active treatment compared to 40.8% for those who were monitored only, a 51% risk reduction.
Darzalex Faspro is now the first approved treatment for high-risk SMM.
The treatment is already approved in multiple myeloma as well as light chain amyloidosis.
