Johnson & Johnson has submitted applications to the FDA and the European Medicines Agency (EMA) for approval of Darzalex Faspro as a subcutaneous monotherapy for adults with high-risk smoldering multiple myeloma.
If approved, the drug would be the first therapy available for this condition, providing an option to treat patients before progression to active multiple myeloma.
Smoldering multiple myeloma is an early, asymptomatic stage of multiple myeloma, with abnormal cells in the bone marrow but no symptoms in patients. About 15% of new multiple myeloma cases are smoldering, and nearly half of high-risk patients progress to active disease within two years. Current treatment typically involves observation until signs of disease progression.
The applications are based on data from the phase 3 aquila study, which is evaluating Darzalex Faspro for high-risk smoldering multiple myeloma. The study findings, to be presented at the 2024 American Society of Hematology annual meeting, measure outcomes such as progression-free survival compared to active monitoring.
