EMA Submission Driven by 83.4% PFS Reduction in Johnson & Johnson’s TECVAYLI/Darzalex Combo
Johnson & Johnson filed to the EMA for TECVAYLI plus Darzalex SC in RRMM after Phase 3 MajesTEC-3 results in 587 patients. The trial cut progression risk by 83.4% (HR 0.17; 95% CI 0.12–0.23; P<0.0001) and kept >90% of six-month responders progression-free at three years.
1. Nipocalimab Phase IIb JASMINE Study Achieves Key Endpoints
Johnson & Johnson reported that its Phase IIb JASMINE trial of nipocalimab in systemic lupus erythematosus enrolled 228 patients across 45 centers in North America and Europe. The study met its primary endpoint with a statistically significant improvement in SLE Responder Index-4 at Week 24, showing a 35% absolute response rate advantage over placebo (p<0.001). Key secondary endpoints included a 40% reduction in median daily corticosteroid dose and a 50% greater decrease in anti–double‐stranded DNA antibody titers. Safety data revealed similar rates of adverse events between nipocalimab and control arms, with no drug-related serious infections reported. These results support J&J’s plan to initiate global Phase III trials in mid-2026 and seek filing approval by late 2028.
2. Johnson & Johnson Submits OTTAVA Robotic System for FDA De Novo Classification
In January 2026 J&J submitted its OTTAVA™ Robotic Surgical System to the FDA under a De Novo classification request, leveraging data from a 12-patient Investigational Device Exemption trial conducted at Memorial Hermann-Texas Medical Center in early 2025. Under lead investigator Dr. Erik Wilson, the soft-tissue system demonstrated successful completion of gastric sleeve, small bowel resection and hiatal hernia procedures with a 98% technical success rate and an average console time of 85 minutes. The IDE trial recorded no device-related adverse events and highlighted OTTAVA’s unified architecture and Ethicon-powered instrumentation. J&J also received IDE approval in late 2025 for a second U.S. trial in inguinal hernia repair, positioning OTTAVA for potential commercialization by 2027 across multiple general surgery indications.