The U.S. Food and Drug Administration approved DARZALEX Faspro®—a co‑formulated daratumumab and hyaluronidase product that uses Halozyme’s ENHANZE® drug‑delivery platform—on November 6, 2025 for adult patients with high‑risk smoldering multiple myeloma (HR‑SMM). This is the first U.S. indication for an active treatment in a disease that has historically been managed only by watchful waiting.
The approval is based on the Phase 3 AQUILA study (NCT03301220), which demonstrated a hazard ratio of 0.49 for progression‑free survival and a 63.1% 5‑year PFS rate with DARZALEX SC versus 40.8% with active monitoring. Roughly 15 % of the 36,000 new multiple‑myeloma cases each year in the United States are smoldering, and about half of those high‑risk patients progress to active disease within two years—statistics that underscore the unmet need addressed by this new indication.
Halozyme’s royalty revenue surged to $236 million in Q3 2025, a 52 % year‑over‑year increase from $155.1 million in Q3 2024, driven by the commercial launch of several ENHANZE‑enabled products, including DARZALEX SC, Phesgo, and VYVGART Hytrulo. Total company revenue rose 22 % to $354 million, and the company raised its full‑year 2025 revenue guidance to $1.30 billion–$1.375 billion from a prior $1.28 billion–$1.36 billion, reflecting confidence in continued demand for its platform. CEO Dr. Helen Torley said the approval “solidifies ENHANZE’s role as a cornerstone technology for subcutaneous biologics and opens a new royalty stream that will support future growth.”
For Janssen/Johnson & Johnson, the expanded indication positions DARZALEX Faspro® as a comprehensive therapy across all stages of multiple myeloma, including the precursor HR‑SMM stage. The drug’s Q3 sales exceeded $3.6 billion, up nearly 20 % year‑over‑year, and the new indication is expected to further accelerate sales as clinicians adopt earlier intervention. Vice President Jordan Schecter noted that the approval “demonstrates our commitment to improving outcomes for patients at every stage of the disease.”
The approval marks a paradigm shift in smoldering multiple myeloma management, moving from passive monitoring to proactive treatment for high‑risk patients. By providing an evidence‑based therapeutic option, the FDA decision is likely to influence future clinical guidelines and could spur additional research into early‑stage interventions across oncology.
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