The FDA has approved daratumumab and hyaluronidase-fihj monotherapy as treatment for adults with high-risk smoldering multiple myeloma, based on results from the randomized phase 3 AQUILA trial.
Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen), a subcutaneous formulation of daratumumab (Darzalex, Janssen), becomes the first FDA-approved therapy for the disease, according to a manufacturer press release.
“Until now, patients diagnosed with smoldering multiple myeloma only have the option to watch and wait for any active signs of progression to active disease,” Peter