EMA Seeks Approval for Tecvayli-Daratumumab Combo After Positive Phase 3 RRMM Results
Johnson & Johnson submitted a Type II variation to the EMA seeking approval to extend TECVAYLI® (teclistamab) plus DARZALEX® SC for relapsed/refractory multiple myeloma after 1–3 prior therapies, based on Phase 3 MajesTEC-3 data showing an 83.4% reduction in risk of progression or death (HR 0.17; 95% CI 0.12–0.23; P<0.0001). The submission follows three-year follow-up demonstrating over 90% of patients progression-free at six months remained so at three years, with similar Grade 3/4 adverse event rates to standard DPd/DVd regimens.
1. Nipocalimab Phase II Success in Systemic Lupus
Johnson & Johnson’s phase IIb JASMINE study of nipocalimab in patients with systemic lupus erythematosus enrolled 228 subjects across 50 centers in North America and Europe. The trial met its primary endpoint, demonstrating a statistically significant reduction in disease activity scores at 24 weeks compared with placebo (p<0.01), and achieved all key secondary endpoints, including improvements in patient-reported fatigue and renal function markers. Safety data showed no new signals, with treatment-related adverse events generally mild to moderate. These results support J&J’s intention to initiate two global phase III studies in mid-2026, positioning nipocalimab as a potential first-in-class FcRn blocker in lupus and addressing an estimated $2.5 billion market for moderate-to-severe SLE therapies.
2. OTTAVA Robotic System Submitted for FDA De Novo Classification
Johnson & Johnson MedTech has filed a De Novo application with the FDA for its OTTAVA™ Robotic Surgical System, leveraging data from a 30-patient IDE study conducted at Memorial Hermann-Texas Medical Center in early 2025. Under the lead of Dr. Erik Wilson, the trial demonstrated successful completion of upper abdomen procedures—gastric sleeve, small bowel resection and hiatal hernia repair—with operative times and intraoperative complication rates comparable to existing platforms. OTTAVA’s unified soft-tissue architecture and Ethicon-powered instrumentation aim to reduce setup time by 20% and instrument exchanges by 30%. A second IDE trial for inguinal hernia repair was approved in late 2025. If cleared, OTTAVA could enter a competitive $5 billion global market for minimally invasive surgical robots by 2027.
3. EMA Submission for TECVAYLI and DARZALEX Combination in RRMM
Johnson & Johnson Innovative Medicine has submitted a Type II variation to the European Medicines Agency to extend approval of teclistamab (TECVAYLI®) combined with daratumumab subcutaneous (DARZALEX® SC) for relapsed/refractory multiple myeloma after one prior line of therapy. The phase III MajesTEC-3 trial enrolled 587 patients and showed an 83.4% reduction in risk of progression or death versus standard regimens (HR 0.17; 95% CI, 0.12–0.23; P<0.0001) at nearly three years’ follow-up. Over 90% of responders at six months remained progression-free at 36 months. Safety profiles were comparable, with Grade 3/4 cytopenias and infections occurring in 95.1% of combination patients versus 96.6% of controls. The application follows Breakthrough Therapy Designation from the FDA and a positive independent data monitoring committee recommendation to unblind the study.