Brussels – The European Commission has granted approval for DARZALEX Faspro® (daratumumab) as a monotherapy for adult patients diagnosed with high-risk smouldering multiple myeloma (SMM). This landmark decision, announced by Janssen-Cilag International NV, a Johnson & Johnson company, marks the first time an approved therapeutic option is available for this precancerous condition, which carries a significant risk of progressing to active multiple myeloma. The approval is poised to transform the management of high-risk SMM, moving beyond the long-standing "watch and wait" approach.
For years, clinicians have faced limited choices for patients with high-risk SMM. "Until now, the absence of approved therapies for high-risk smouldering multiple myeloma has left clinicians with limited options beyond observation, despite evidence that 50 percent of this patient population progress to active multiple myeloma within two years," stated Professor Meletios A. Dimopoulos, M.D., National and Kapodistrian University of Athens School of Medicine. This new approval directly addresses that critical unmet need.
The EC's decision is supported by robust data from the Phase 3 AQUILA study, which evaluated the efficacy and safety of fixed-duration monotherapy daratumumab compared with active monitoring. Results from the study demonstrated that daratumumab significantly reduced the risk of progression to active multiple myeloma or death by 51 percent. This substantial reduction highlights the potential for early intervention to alter the disease course.
Smouldering multiple myeloma is an asymptomatic intermediate disease state where abnormal plasma cells accumulate in the bone marrow. While not yet symptomatic, high-risk SMM patients are at a considerably elevated risk of developing symptomatic multiple myeloma, often within a short timeframe. The availability of daratumumab offers a proactive treatment strategy to delay or potentially prevent this progression.
This approval represents a significant advancement in the field of hematology, providing a new pathway for managing high-risk SMM. It is expected to improve patient outcomes by offering a therapeutic option that can delay the onset of active multiple myeloma, thereby potentially reducing the need for more intensive and continuous treatments later. The move underscores a growing trend towards earlier therapeutic intervention in precursor conditions to prevent full-blown disease.