Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO®/DARZALEX® (daratumumab) as subcutaneous monotherapy for high-risk smouldering multiple myeloma
November 8, 2024 – Clinical Trials, Drug Discovery, Pharmaceutical – Johnson & Johnson, Johnson & Johnson Innovative Medicine, oncology, smouldering multiple myeloma
If approved, daratumumab will become the first treatment option for patients with smouldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage
6 November 2024 — Beerse, Belgium — Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of a new indication for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in the U.S. and DARZALEX® (daratumumab)subcutaneous (SC) formulation in the European Union (EU). The applications are supported by data from the ongoing Phase 3 AQUILA study (NCT03301220) of daratumumab SC as monotherapy for the treatment of adult patients with high-risk smouldering multiple myeloma.
Smouldering multiple myeloma is an early precursor of active multiple myeloma, where abnormal cells can be detected in the bone marrow, but patients are typically asymptomatic. Fifteen percent of all cases of newly diagnosed multiple myeloma are classified as smouldering multiple myeloma, and half of those diagnosed with high-risk disease will progress to active multiple myeloma within two years. Currently, smouldering multiple myeloma is not generally treated until active multiple myeloma develops. Instead, the standard approach is observation to track the disease for signs of biochemical progression and/or end organ damage, when treatment tends to be initiated. Recent evidence suggests that those at high-risk for progression to active multiple myeloma could benefit from earlier therapeutic intervention.
“There remains an unmet need for early interventions and treatments that are both effective and well tolerated in people living with smouldering 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. “Daratumumab 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 smouldering multiple myeloma, potentially shifting the treatment paradigm.”
The first data from the AQUILA study, evaluating the safety and efficacy of 3 years fixed duration daratumumab SC compared to active monitoring in participants with high-risk smouldering multiple myeloma, will be presented at the 2024 American Society of Hematology (ASH) Annual Meeting, taking place in San Diego from December 7-10.
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