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Innovative Medicine
Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study
· Nipocalimab – the first and only neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus – is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with this disease while preserving immune function · Results demonstrated significant reduction of systemic lupus erythematosus disease activity which continued beyond the 24-week primary endpoint, and were sustained through Week 52 in the nipocalimab 15 mg/kg groupa · The ongoing Phase 3 study of nipocalimab is currently recruiting people living with systemic lupus erythematosus – a debilitating autoantibody-driven disease which can lead to systemic organ damage
Johnson & Johnson presents new data further reinforcing the role of nipocalimab in lowering the autoantibodies driving Sjögren’s disease
· Nipocalimab, an immunoselective neonatal Fc receptor (FcRn) blocker, is designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies associated with Sjögren’s disease while preserving immune function · New exploratory analysis of Phase 2 study data shows a strong correlation between autoantibody levels and even greater clinical response rates of participants in the nipocalimab treatment group · Previously reported data from the Phase 2 study showed nipocalimab reduced Sjögren’s disease activity and severity, with potential to address systemic manifestations and the most burdensome patient-reported symptoms including dryness, fatigue and pain · Nipocalimab is the only FcRn blocker granted both Breakthrough Therapy Designation and Fast Track Designation by the U.S. FDA for the treatment of adults with moderate-to-severe Sjögren’s disease.
Johnson & Johnson’s Phase 3 prostate cancer study shows ERLEADA® (apalutamide) before and after surgery significantly reduces risk of metastasis or death, breaking a decades-long treatment paradigm
• Patients were nine times more likely to have little to no cancer remaining in the prostate after surgery, with a 20% reduction in the risk of developing metastasis or death • Data selected to open the plenary presentation at ASCO 2026 and published in The New England Journal of Medicine
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limited
• More than one-third of responders with previously treated disease achieved complete responses, with median duration of response not yet reached, as reported in new Journal of Clinical Oncology publication • RYBREVANT FASPRO™, an EGFR- and MET-targeting dual inhibitor, is the first and only subcutaneous therapy being evaluated in this setting • Johnson & Johnson submitted a supplemental Biologics License Application to U.S. FDA seeking approval for this indication
RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) demonstrates prolonged clinical benefit as a first-line treatment for atypical EGFR-mutated non-small cell lung cancer
• Median overall survival, a secondary endpoint, reached nearly 3.5 years with Johnson & Johnson’s RYBREVANT® plus LAZCLUZE® in atypical EGFR-mutated disease • Consistent responses observed across atypical EGFR mutation subgroups, including those historically associated with poorer outcomes • ASCO 2026 results reinforce the significance of RYBREVANT®-based regimens for patients across EGFR mutations
New TECVAYLI® data demonstrates superior progression-free and overall survival as early as first relapse in multiple myeloma
• Building on the recent approval of TECVAYLI® plus DARZALEX FASPRO®, MajesTEC-9 is the second positive Phase 3 study to reinforce the strength of TECVAYLI® as early as second line • TECVAYLI®delivered deep and durable responses, with nearly two-thirds of patients achieving a complete response or better
FDA approves label expansion, cementing TREMFYA® as the only IL‑23 inhibitor proven to help stop further joint damage
TREMFYA® showed significant inhibition of structural joint damage in adults with active psoriatic arthritis
Groundbreaking global survey captures the significant patient burden experienced with current standard-of-care bladder cancer treatments, underscoring urgency for continued innovation
• More than 90% of patients surveyed who underwent bladder removal or received BCG report negative impact on most aspects of their lives • Among patients treated with BCG, three-quarters describe managing the treatment-related physical symptoms as humiliating • Patients and urologists point to the importance of advancing treatments that may better reflect patient preferences and quality‑of‑life considerations
Johnson & Johnson showcases hematology leadership with 30+ presentations at the 2026 European Hematology Association (EHA) Congress
· Johnson & Johnson will present 30+ abstracts at European Hematology Association 2026, highlighting leadership in hematology with data across multiple myeloma and leukemia, and first pivotal data in warm autoimmune hemolytic anemia · Phase 3 results evaluate the potentially transformative investigational combination of TALVEY®, the first GPRC5D‑targeted bispecific antibody, in combination with DARZALEX FASPRO® with or without pomalidomide for patients with relapsed or refractory multiple myeloma in earlier lines of therapy · Pivotal Phase 2/3 results potentially position IMAAVY® as the first FDA-approved treatment for warm autoimmune hemolytic anemiaa designed to target the IgG autoantibodies responsible for red blood cell destruction