Johnson & Johnson has received approval from the US Food and Drug Administration (FDA) for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) as a treatment for adults with high-risk smouldering multiple myeloma (HR-SMM).
Smouldering multiple myeloma (SMM) is a precursor disease state to multiple myeloma, where abnormal cells can be detected in the bone marrow but patients do not display symptoms typically associated with active myeloma, such as bone pain or fractures, kidney problem or anaemia. Despite the absence of symptoms, disease progression can occur silently, with approximately 50% of HR-SMM cases advancing to active multiple myeloma within two years.
With this approval, DARZALEX FASPRO becomes the first and only therapy indicated for HR-SMM, offering an alternative to the current standard of care – active monitoring for biochemical progression or end-organ damage.
The decision was supported by data from the randomised, multicentre phase 3 AQUILA trial, which evaluated DARZALEX FASPRO monotherapy versus observation in patients with SMM. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival, reducing the risk of progression to multiple myeloma or death. Key secondary endpoints, including overall response rate, overall survival, and time to first-line treatment, also showed positive trends with a consistent safety profile.
“DARZALEX FASPRO is a foundational therapy in multiple myeloma and illustrates our commitment to improve outcomes for patients at every stage of their disease,” said Jordan Schecter, Vice President, Research & Development, Multiple Myeloma, Oncology, Johnson & Johnson Innovative Medicine. “Data from the AQUILA study reinforce the significant impact DARZALEX FASPRO continues to have for patients. With today’s approval, patients with HR-SMM will now be able to receive this treatment before they progress to active multiple myeloma, giving us the opportunity to shift the treatment paradigm and bring hope to people who are impacted by this disease.”