J&J(US:JNJ) Prnewswire·2025-11-06 22:07Core Insights - The FDA has approved DARZALEX FASPRO as the first treatment for high-risk smoldering multiple myeloma, marking a significant advancement in early intervention for this condition [1][2][6] Study Findings - The Phase 3 AQUILA study demonstrated that DARZALEX FASPRO reduced the risk of progression to active multiple myeloma or death by 51% compared to active monitoring [2][4] - After a median follow-up of 65.2 months, 63.1% of patients treated with DARZALEX FASPRO had not progressed to active myeloma at 5 years, compared to 40.7% in the active monitoring group [4] - The overall response rate for patients receiving DARZALEX FASPRO was 63.4%, significantly higher than the 2.0% observed in the active monitoring group [5] Patient Demographics - In 2025, over 36,000 people are expected to be diagnosed with multiple myeloma in the U.S., with approximately 15% classified as smoldering [3][10] - About 50% of patients diagnosed with high-risk smoldering multiple myeloma are likely to progress to active disease within two years [3][11] Treatment Paradigm Shift - The approval of DARZALEX FASPRO allows for earlier therapeutic intervention, shifting the treatment paradigm for patients with high-risk smoldering multiple myeloma [6][4] - The standard of care for high-risk smoldering multiple myeloma has been active monitoring, but recent evidence suggests that earlier intervention could be beneficial [3][4] Safety and Adverse Reactions - Common adverse reactions observed in the AQUILA study included upper respiratory tract infection, musculoskeletal pain, fatigue, and injection site reactions [7][42] - Serious infections occurred in 24% of patients, with pneumonia being the most common serious infection reported [23][42] Future Research - A subgroup analysis of the AQUILA study will be presented at the 2025 ASH Annual Meeting, focusing on the efficacy and safety of DARZALEX FASPRO using updated risk models [8]