Johnson & Johnson announced that the U.S. Food and Drug Administration approved its drug DARZALEX FASPRO (daratumumab and hyaluronidase‑fihj) as a single‑agent therapy for adult patients with high‑risk smoldering multiple myeloma (HR‑SMM). The approval, granted on November 6, 2025, marks the first and only FDA‑cleared treatment for this early‑stage disease.
The decision was based on the Phase 3 AQUILA study, which demonstrated a 51 % reduction in the risk of progression to active multiple myeloma or death compared with active monitoring. The study’s results support a shift from the traditional “watch‑and‑wait” approach to proactive treatment for patients who have a high likelihood of disease progression.
Strategically, the approval expands J&J’s oncology portfolio and reinforces its Innovative Medicine strategy, which prioritizes high‑growth, high‑impact therapies. By offering an earlier intervention, the company positions itself as a pioneer in disease interception, a key focus area for its oncology division.
HR‑SMM represents roughly 15 % of new multiple myeloma diagnoses in the United States, and about half of those patients progress to active disease within two years. Prior to this approval, no therapy was available for this patient group, creating a sizable unmet need and a niche market opportunity for J&J.
Dr. Jordan Schecter, Vice President of Research & Development for Multiple Myeloma at J&J, said, “DARZALEX FASPRO is a foundational therapy in multiple myeloma and illustrates our commitment to improve outcomes for patients at every stage of their disease. With today’s approval, patients with HR‑SMM will now be able to receive this treatment before they progress to active multiple myeloma.” Dr. Helen Torley, President and CEO of Halozyme, added, “DARZALEX FASPRO is the first approved treatment in the U.S. for adult patients with high‑risk smoldering multiple myeloma, further solidifying its role as a cornerstone therapy across all stages of the disease.”
The new indication is expected to generate a new revenue stream for J&J’s Innovative Medicine segment and gives the company a first‑mover advantage in a previously untapped market. The approval also underscores the success of J&J’s antibody platform and its focus on high‑margin, high‑impact therapies.
Analysts note that the approval is a significant milestone for J&J’s oncology strategy, highlighting the company’s ability to translate clinical data into regulatory success and market opportunity. The move is expected to strengthen the company’s position in the competitive multiple myeloma landscape and support its broader growth objectives.
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