The US Food and Drug Administration has approved daratumumab co-formulated with hyaluronidase (DARZALEX FASPRO®), as a single-agent therapy for adults with high-risk smoldering multiple myeloma (HR-SMM).
The approval was announced by Johnson & Johnson in a press release on November 6, 2025. The company said in the release that the therapy is the first and only approved treatment for HR-SMM.
The FDA approval is based on findings from the phase 3 AQUILA study, which showed that daratumumab monotherapy in patients with high-risk smoldering multiple myeloma demonstrated “an opportunity to delay or even prevent end-organ damage and progression to MM while maintaining quality of life and improving survival,” according to the investigators of that study.
The phase 3 AQUILA study is a randomized, multicenter study comparing treatment with DARZALEX FASPRO® to active monitoring in patients with SMM. Patients received single agent DARZALEX FASPRO® as a fixed-duration treatment for up to 36 months.
“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 Voorhees, MD, of Atrium Health/Levine Cancer Institute in Charlotte, North Carolina, said in the J&J release. “Results from AQUILA demonstrated DARZALEX FASPRO significantly delayed disease progression, underscoring the role of early disease intervention for patients with high-risk smoldering multiple myeloma.”
