Johnson & Johnson has announced regulatory submissions to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S. and DARZALEX subcutaneous (SC) formulation in the European Union (EU) for a new indication. The applications target the treatment of adult patients with high-risk smoldering multiple myeloma as a monotherapy.
The submissions are supported by data from the Phase 3 AQUILA study (NCT03301220), which evaluated the safety and efficacy of DARZALEX FASPRO compared to active monitoring in participants with high-risk smoldering multiple myeloma. Detailed findings from the AQUILA study are scheduled for presentation at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego.
Unmet Need in Smoldering Multiple Myeloma
Smoldering multiple myeloma represents an early stage of multiple myeloma, characterized by the presence of abnormal cells in the bone marrow without overt symptoms. Approximately 15% of newly diagnosed multiple myeloma cases are classified as smoldering, with half of high-risk patients progressing to active multiple myeloma within two years. Currently, the standard of care involves monitoring patients for signs of biochemical progression or end-organ damage before initiating treatment.
"There remains an unmet need for early interventions and treatments that are both effective and well tolerated in people living with smoldering multiple myeloma at high-risk of progressing to active multiple myeloma," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Innovative Medicine, Johnson & Johnson. "DARZALEX has changed the standard of care in multiple myeloma, and with these submissions to the FDA and EMA, this therapy could become the first approved treatment for patients with high-risk smoldering multiple myeloma, potentially shifting the treatment paradigm."
Potential Impact on Treatment Paradigm
If approved, Darzalex Faspro could represent a significant advancement in the management of high-risk smoldering multiple myeloma, offering an earlier therapeutic intervention to potentially delay or prevent progression to active disease. This approach contrasts with the current standard of care, which typically involves observation until the development of active myeloma.
