Johnson & Johnson has submitted an application to the Food and Drug Administration (FDA) seeking approval for Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma. This submission marks a potential shift in the treatment paradigm, offering the first approved therapy for this patient population.
Unmet Need in Smoldering Multiple Myeloma
Smoldering multiple myeloma is a slow-growing form of myeloma characterized by an overproduction of monoclonal antibodies. Approximately 15% of patients diagnosed with multiple myeloma are classified as having the smoldering form. A significant proportion, about half of those with high-risk disease, progress to active multiple myeloma within two years. Currently, these patients are typically monitored without active treatment until the disease progresses.
Dr. Yusri Elsayed, Global Therapeutic Area Head, Oncology, Innovative Medicine at Johnson & Johnson, stated, "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."
AQUILA Trial Details
The FDA application is supported by data from the ongoing phase 3 AQUILA study. This trial is evaluating Darzalex Faspro as a monotherapy compared to active monitoring in 390 patients diagnosed with smoldering multiple myeloma within the past five years. Patients with prior treatment for smoldering or active multiple myeloma were excluded from the study.
The primary endpoint of the AQUILA trial is progression-free survival (PFS), defined as the time during and after treatment when the patient lives with the disease without worsening. Secondary endpoints include overall response rate (ORR), time to progression (TTP), and overall survival (OS).
First findings from the AQUILA trial are expected to be presented at the 2024 American Society of Hematology (ASH) Annual Meeting in December.
Darzalex Faspro's Established Role in Multiple Myeloma
Darzalex Faspro received its initial FDA approval in May 2020 and has since been approved for nine other indications in multiple myeloma, including four frontline treatments for newly diagnosed patients regardless of transplant eligibility. The potential approval for high-risk smoldering multiple myeloma could further expand its role in managing the disease continuum.
