Johnson & Johnson Seeks U.S. and EU Approval for Subcutaneous DARZALEX® in High-Risk Smouldering Multiple Myeloma
Monday, November 11, 2024
Johnson & Johnson has submitted regulatory applications to both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a new indication for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in the U.S. and DARZALEX® subcutaneous (SC) formulation in the European Union.
Smoldering multiple myeloma is a precursor to active multiple myeloma, featuring elevated abnormal plasma cells in the bone marrow and increased monoclonal protein (M-protein) levels in the blood, although without symptoms commonly linked to active disease.
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), first approved by the FDA in May 2020, is the only subcutaneous CD38-directed antibody authorised for multiple myeloma and is used across nine indications, including first-line treatment for both transplant-eligible and ineligible patients.
This submission is backed by data from the Phase 3 AQUILA study (NCT03301220), which evaluates DARZALEX FASPRO® as a monotherapy for adults with high-risk smoldering multiple myeloma.
Smoldering multiple myeloma, an early stage of multiple myeloma, is marked by the presence of abnormal cells in the bone marrow, although patients generally remain without symptoms.
This stage represents around 15% of newly diagnosed multiple myeloma cases, and among high-risk patients, about half may develop active multiple myeloma within two years. Standard practice for smoldering multiple myeloma generally involves observation until signs of progression to active multiple myeloma appear, with treatment typically starting upon detection of biochemical changes or organ damage.
Recent research suggests early treatment could benefit high-risk patients by potentially delaying disease progression.
The first results from the AQUILA study, examining the safety and efficacy of DARZALEX FASPRO® compared to active monitoring in high-risk smoldering multiple myeloma patients, will be presented at the American Society of Hematology (ASH) Annual Meeting in December 2024.
Source: jnj.com
