Johnson & Johnson (J&J) has submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval for Darzalex Faspro (daratumumab and hyaluronidase-fihj) as a monotherapy for adult patients with high-risk smoldering multiple myeloma. If approved, Darzalex Faspro would become the first treatment available for this early precursor stage of active multiple myeloma.
Smoldering multiple myeloma is characterized by the presence of abnormal cells in the bone marrow, but patients are typically asymptomatic. According to J&J, there is an unmet need for early interventions in individuals with smoldering myeloma who are at high risk of progressing to active disease.
The applications are based on data from the Phase 3 AQUILA study, a multicenter, randomized trial evaluating Darzalex Faspro versus no treatment in patients with high-risk smoldering myeloma. The results of the AQUILA study are scheduled to be presented at the American Society of Hematology (ASH) annual meeting in December 2024.
Darzalex Faspro's Existing Approvals
Darzalex Faspro received FDA approval in 2020 for five indications in multiple myeloma, including newly diagnosed, relapsed, transplant-ineligible, and refractory patients. The drug has become a standard of care in multiple myeloma treatment.
Potential Impact on Treatment Paradigm
"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 MD, MHSc, PhD, 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."
