The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) has voted 6-2 in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as a monotherapy for adults with high-risk smoldering multiple myeloma (HR-SMM). This recommendation is based on the Phase 3 AQUILA study, which demonstrated that DARZALEX FASPRO significantly reduced the risk of progression to active multiple myeloma or death by 51% compared to active monitoring. At five years, 63.1% of patients treated with DARZALEX FASPRO remained progression-free, versus 40.8% in the monitoring group.
Currently, there are no FDA-approved treatments for HR-SMM, a condition where approximately 50% of patients progress to active multiple myeloma within two to three years. If approved, DARZALEX FASPRO would become the first therapy available to delay or potentially prevent this progression, marking a potential paradigm shift in early myeloma intervention.
While the ODAC’s recommendation is non-binding, it strongly supports FDA approval. A final decision is expected later this year.