Core Insights - The FDA approved Johnson & Johnson's Darzalex Faspro for high-risk smoldering multiple myeloma, marking it as the first approved treatment for this condition [1] - The approval is based on the AQUILA study, which showed a 51% reduction in the risk of disease progression compared to active monitoring [2] - Johnson & Johnson's Caplyta was also approved as an adjunctive therapy for major depressive disorder, marking its fourth indication [4][5] Group 1: Darzalex Faspro Approval - Darzalex Faspro is the first and only approved treatment for high-risk smoldering multiple myeloma, allowing for earlier intervention [1] - The AQUILA study demonstrated a significant improvement in progression-free survival (PFS), with a 51% reduction in the risk of progression to active myeloma or death [2] - After a median follow-up of 65.2 months, 63.1% of patients on Darzalex Faspro had not progressed to active myeloma at five years, compared to 40.7% in the active monitoring group [3] Group 2: Caplyta Approval - Caplyta received FDA approval as an adjunctive therapy for major depressive disorder, marking its fourth indication [4][5] - The approval is based on two Phase 3 trials that met primary and key secondary endpoints, showing significant improvement in depression symptoms compared to an oral antidepressant plus placebo [5] Group 3: Treatment Timing - Patients receiving Darzalex Faspro experienced a delay in the median time to first-line multiple myeloma treatment, with a median time of not reached (NR) compared to 50.2 months for the active monitoring group [4]