Johnson & Johnson’s DARZALEX Faspro received FDA approval for treatment of adult patients with high‑risk smoldering multiple myeloma, offering the first approved therapy for this earlier disease stage. The subcutaneous formulation leverages Halozyme’s ENHANZE hyaluronidase delivery technology to enable convenient administration. The approval expands DARZALEX’s label into a population at high risk of progression to overt myeloma, based on randomized trial data showing reductions in progression metrics. J&J said the approval supports earlier intervention strategies and could reshape management pathways for patients who previously received surveillance alone. Clinicians will evaluate patient selection and long‑term outcomes; payers will review coverage criteria given the preventive intent and implications for treatment timing in the multiple myeloma continuum.