Johnson & Johnson’s DARZALEX FASPRO® Receives Approval for the Treatment of High-Risk Smouldering Multiple Myeloma
Friday, November 07, 2025
Johnson & Johnson has announced that the United States Food and Drug Administration (FDA) has approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as a single-agent therapy for adults with high-risk smouldering multiple myeloma (HR-SMM).
Multiple myeloma is a blood cancer that affects plasma cells in the bone marrow. It is the second most common blood cancer worldwide and remains incurable. The disease is expected to affect more than 36,000 people in the United States in 2025, with over 12,000 deaths projected. The five-year survival rate stands at 59.8%.
Smouldering multiple myeloma (SMM) is a precursor stage of multiple myeloma, in which abnormal plasma cells are present in the bone marrow but without the symptoms typical of active disease. Although asymptomatic, it can progress silently to active multiple myeloma.
Smouldering multiple myeloma (SMM) is an asymptomatic condition that shares similar genetic features with active multiple myeloma. In 2025, more than 36,000 people in the United States are expected to be diagnosed with multiple myeloma, with around 15% classified as having smouldering disease. Approximately half of HR-SMM patients are expected to develop active myeloma within two years of diagnosis. Until now, active monitoring has been the standard of care for this condition.
DARZALEX FASPRO®, first approved by the FDA in May 2020, is indicated for ten multiple myeloma conditions, including four frontline treatment settings for newly diagnosed patients. It is the only subcutaneous CD38-directed antibody therapy for multiple myeloma, formulated with Halozyme’s ENHANZE® drug delivery technology.
This marks the first and only approved treatment for HR-SMM, enabling earlier therapeutic intervention before the disease progresses to active multiple myeloma.
The approval is based on results from the AQUILA Phase 3 study (NCT03301220), which compared DARZALEX FASPRO® with active monitoring, also known as the “watch and wait” approach. The study demonstrated a significant improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 51% compared with active monitoring.
The decision follows the May 2025 recommendation from the FDA’s Oncologic Drugs Advisory Committee (ODAC) in support of the treatment’s benefit–risk profile for HR-SMM patients.
Source: jnj.com
